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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL096978 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| CAS Medical Systems, Inc. | INDUSTRY |
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The purpose of this study is to see if a drug called lidocaine prevents cognitive injury (a decline in mental abilities) after heart surgery. Lidocaine is currently FDA approved and is commonly used for treating some heart rhythm disorders and for regional anesthesia (blocking nerves). The investigators are enrolling subjects in this research project to see if lidocaine will reduce the high incidence of cognitive injury seen after heart surgery. As part of this study, the investigators will also evaluate the relationship between cognitive injury and genetic makeup and the chemical changes in the subjects blood during and after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Experimental | Lidocaine infusion for 48 hours |
|
| Placebo | Placebo Comparator | Normal saline infusion for 48 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Lidocaine versus placebo infusion for 48 hours |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cognitive Function From Baseline Characterized as Continuous Cognitive Change | To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline. We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 5 preoperative domain scores. The cognitive index score has a mean of zero, thus any positive score is above the mean, any negative score is below the mean. A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index. The resulting outcome measure is unbounded with standard deviation of 0.35. A negative change score indicating decline and a positive score indicating improvement. | Preoperative to 6 weeks after surgery |
| Count of Participants With a Decline of Greater Than or Equal to One Standard Deviation in One or More of Five Cognitive Domain Scores Reported as a Dichotomous Post-operative Cognitive Deficit (POCD) Outcome | To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline. We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration. Each domain score is normally distributed with a mean of zero. A change score was calculated for each domain by subtracting the baseline from the 6-week score. A dichotomous outcome variable of post-operative cognitive deficit was defined as a decline of ≥1 standard deviation in 1 or more of the 5 domains. | Preoperative to 6 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Transcerebral Activation Gradients of Platelets | Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removalime points and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph P Mathew, M. D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States | ||
| Sentara Cardiovascular Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11172175 | Background | Newman MF, Kirchner JL, Phillips-Bute B, Gaver V, Grocott H, Jones RH, Mark DB, Reves JG, Blumenthal JA; Neurological Outcome Research Group and the Cardiothoracic Anesthesiology Research Endeavors Investigators. Longitudinal assessment of neurocognitive function after coronary-artery bypass surgery. N Engl J Med. 2001 Feb 8;344(6):395-402. doi: 10.1056/NEJM200102083440601. | |
| 11739990 | Background | Newman MF, Grocott HP, Mathew JP, White WD, Landolfo K, Reves JG, Laskowitz DT, Mark DB, Blumenthal JA; Neurologic Outcome Research Group and the Cardiothoracic Anesthesia Research Endeavors (CARE) Investigators of the Duke Heart Center. Report of the substudy assessing the impact of neurocognitive function on quality of life 5 years after cardiac surgery. Stroke. 2001 Dec 1;32(12):2874-81. doi: 10.1161/hs1201.099803. |
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550 participants consented; 478 participants were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lidocaine | Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours |
| FG001 | Placebo | Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Number of participants who completed the study are included in the baseline analysis population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lidocaine | Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours |
| BG001 | Placebo | Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Cognitive Function From Baseline Characterized as Continuous Cognitive Change | To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline. We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 5 preoperative domain scores. The cognitive index score has a mean of zero, thus any positive score is above the mean, any negative score is below the mean. A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index. The resulting outcome measure is unbounded with standard deviation of 0.35. A negative change score indicating decline and a positive score indicating improvement. | Posted | Mean | Standard Deviation | units on a scale | Preoperative to 6 weeks after surgery |
|
Adverse events were collected until hospital discharge (approximately 4 -10 days) . Serious Adverse Events were reported up to one year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lidocaine | Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Blood Loss anemia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Dysrhythmia - Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Mathew, M.D | Duke University Health System | 919-681-6646 | joseph.mathew@duke.edu |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Placebo |
| Drug |
Lidocaine versus placebo infusion for 48 hours |
|
| Baseline to 6 hours post cross-clamp removal |
| Transcerebral Activation Gradients of Neutrophils | Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removal and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups | Baseline to 6 hours post cross-clamp removal |
| Transcerebral Activation Gradients of Monocytes | Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removalime points and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups | Baseline to 6 hours post cross-clamp removal |
| Transcerebral Activation Gradient of Platelet-neutrophil Conjugates | Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removalime points and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups | Baseline to 6 hours post cross-clamp removal |
| Change in Cognitive Function From Baseline | To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline. We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 5 preoperative domain scores. The cognitive index score has a mean of zero, thus any positive score is above the mean, any negative score is below the mean. A continuous change score was then calculated by subtracting the baseline from the 1 year cognitive index. The resulting outcome measure is unbounded with standard deviation of 0.35. A negative change score indicating decline and a positive score indicating improvement | 1 year after surgery |
| Change in Duke Activity Status Index (DASI) | The DASI is a 12-item scale of functional capacity that has been found to correlate well with objective measures of maximal exercise capacity. Items reflect activities of personal care, ambulation, household tasks, sexual function, and recreational activities. Activities done "with no difficulty" receive scores, which are weighted and summed, for a quantitative measure of functional status. Scores range from 0 to 60; a higher-weighted score indicates better function. | baseline, 6-weeks |
| Change in Duke Activity Status Index (DASI) | The DASI is a 12-item scale of functional capacity that has been found to correlate well with objective measures of maximal exercise capacity. Items reflect activities of personal care, ambulation, household tasks, sexual function, and recreational activities. Activities done "with no difficulty" receive scores, which are weighted and summed, for a quantitative measure of functional status. Scores range from 0 to 60; a higher-weighted score indicates better function. | baseline, 1-year |
| Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS) | The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient). | baseline, 6-weeks |
| Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS) | The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient). | baseline, 1-year |
| Change in Center for Epidemiological Studies Depression Scale (CES-D) | Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a 20-item self-report examination designed to measure symptoms of depression. Subjects rate the degree to which they have experienced a range of symptoms of depression, such as "I had crying spells" and "I felt lonely." Scores range from 0 to 60, with higher scores indicating greater depressive symptoms. Scores greater than 16 are typically considered indicative of clinically significant depression. | baseline, 6-weeks |
| Change in Center for Epidemiological Studies Depression Scale (CES-D) | Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a 20-item self-report examination designed to measure symptoms of depression. Subjects rate the degree to which they have experienced a range of symptoms of depression, such as "I had crying spells" and "I felt lonely." Scores range from 0 to 60, with higher scores indicating greater depressive symptoms. Scores greater than 16 are typically considered indicative of clinically significant depression. | baseline, 1-year |
| Change in Spielberger State Anxiety Inventory (STAI) | Spielberger State Anxiety Inventory (STAI): The STAI consists of two 20-item scales that measure anxiety. Representative items include statements such as "I feel nervous" and "I feel worried." These items are rated on a 4-point scale, based on how well they describe the patient's current or typical mood, from "not at all" to "very much so." Scores range from 20 to 80, with higher scores indicating greater anxiety. | baseline, 6-weeks |
| Change in Spielberger State Anxiety Inventory (STAI) | Spielberger State Anxiety Inventory (STAI): The STAI consists of two 20-item scales that measure anxiety. Representative items include statements such as "I feel nervous" and "I feel worried." These items are rated on a 4-point scale, based on how well they describe the patient's current or typical mood, from "not at all" to "very much so." Scores range from 20 to 80, with higher scores indicating greater anxiety. | baseline, 1-year |
| Change in Symptom Limitations | Symptom limitations: Patients were given a list of eight symptoms and asked to rate the degree to which the symptom limited daily activities. The symptoms were angina, shortness of breath, arthritis, back trouble, leg pains, headaches, fatigue, and other. Scores range from 8 to 32, with higher scores indicating greater limitations. | baseline, 6-weeks |
| Change in Symptom Limitations | Symptom limitations: Patients were given a list of eight symptoms and asked to rate the degree to which the symptom limited daily activities. The symptoms were angina, shortness of breath, arthritis, back trouble, leg pains, headaches, fatigue, and other. Scores range from 8 to 32, with higher scores indicating greater limitations. | baseline, 1-year |
| Change in the Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL) | Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL): This measure contains six items that assess the ability to perform important tasks for daily living (e.g., "Could you prepare your own meals?" "Could you drive a car?"). Scores range from 6 to 24. Higher scores indicate increasing difficulty in engaging in daily activities. | baseline, 6-weeks |
| Change in the Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL) | Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL): This measure contains six items that assess the ability to perform important tasks for daily living (e.g., "Could you prepare your own meals?" "Could you drive a car?"). Scores range from 6 to 24. Higher scores indicate increasing difficulty in engaging in daily activities. | baseline, 1-year |
| Change in the Cognitive Difficulties Scale | Cognitive Difficulties Scale: a 39-item scale, is a self-report assessment of perceived problems in long- and short-term memory, concentration, attention, and psycho-motor coordination. Sample items are "I forget errands I planned to do" and "I fail to recognize people I know." Scores range from 39 to 164, with higher scores indicating greater cognitive difficulty. | baseline, 6-weeks |
| Change in the Cognitive Difficulties Scale | Cognitive Difficulties Scale: a 39-item scale, is a self-report assessment of perceived problems in long- and short-term memory, concentration, attention, and psycho-motor coordination. Sample items are "I forget errands I planned to do" and "I fail to recognize people I know." Scores range from 39 to 164, with higher scores indicating greater cognitive difficulty. | baseline, 1-year |
| Change in Perceived Social Support | Perceived Social Support Scale: Twelve items indicate how strongly subjects agree that there is "a special person who is around when I am in need" and "my family really tries to help me." Choices range from "very strongly disagree" to "very strongly agree." Items are summed for a range of 12 to 84, with a high score meaning more social support. | baseline, 6-weeks |
| Change in Perceived Social Support | Perceived Social Support Scale: Twelve items indicate how strongly subjects agree that there is "a special person who is around when I am in need" and "my family really tries to help me." Choices range from "very strongly disagree" to "very strongly agree." Items are summed for a range of 12 to 84, with a high score meaning more social support. | baseline, 1-year |
| Change in Social Activity | Social Activity: This measure consisted of eight items that indicate the degree of social interaction. Sample items are "How often do you talk on the telephone with friends and relatives?" and "How often do you attend meetings of social groups, clubs, or civic organizations?" Scores range from 8 to 32. A lower score indicates more social activity. | baseline, 6-weeks |
| Change in Social Activity | Social Activity: This measure consisted of eight items that indicate the degree of social interaction. Sample items are "How often do you talk on the telephone with friends and relatives?" and "How often do you attend meetings of social groups, clubs, or civic organizations?" Scores range from 8 to 32. A lower score indicates more social activity. | baseline, 1-year |
| Change in Study 36-Item Short Form Health Survey (SF-36) | The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36): The SF-36 was designed to measure general health status. Two scales were used: Work Activities (four items) and General Health (one item). For the work activities scale, the reported score was the sum of four questions, each with values ranging from 1 to 4, the total score could range from 4 to 16. A higher score on Work Activities indicates more health-related problems For the general health question, the patients ranked their health from Excellent (1) to poor (5), the scale ranged from 1 to 5 with 1 being best health and 5 being worst. A high score in General Health indicates poorer health state. | baseline, 6-weeks |
| Change in Study 36-Item Short Form Health Survey (SF-36) | The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36): The SF-36 was designed to measure general health status. Two scales were used: Work Activities (four items) and General Health (one item). For the work activities scale, the reported score was the sum of four questions, each with values ranging from 1 to 4, the total score could range from 4 to 16. A higher score on Work Activities indicates more health-related problems For the general health question, the patients ranked their health from Excellent (1) to poor (5), the scale ranged from 1 to 5 with 1 being best health and 5 being worst. A high score in General Health indicates poorer health state. | baseline, 1-year |
| Change in Neurological Function, as Measured by the Western Perioperative Neurologic Scale (WPNS) | The Western perioperative neurologic scale was designed to detect neurologic deficits after cardiac surgery. It includes 14 items classified into eight domains (mentation, speech, cranial nerve function, motor weakness, sensation and cerebellum, reflexes, and gait). Each item is scored from 0 (severe deficit) to3 (normal), and a maximum score of 42 indicates normal neurological function. | baseline, 6-weeks |
| Change in Neurological Function, as Measured by the Western Perioperative Neurologic Scale (WPNS) | The Western perioperative neurologic scale was designed to detect neurologic deficits after cardiac surgery. It includes 14 items classified into eight domains (mentation, speech, cranial nerve function, motor weakness, sensation and cerebellum, reflexes, and gait). Each item is scored from 0 (severe deficit) to3 (normal), and a maximum score of 42 indicates normal neurological function. | baseline, 1-year |
| Norfolk |
| Virginia |
| 23507 |
| United States |
| 16738066 | Background | Phillips-Bute B, Mathew JP, Blumenthal JA, Grocott HP, Laskowitz DT, Jones RH, Mark DB, Newman MF. Association of neurocognitive function and quality of life 1 year after coronary artery bypass graft (CABG) surgery. Psychosom Med. 2006 May-Jun;68(3):369-75. doi: 10.1097/01.psy.0000221272.77984.e2. |
| 19164788 | Background | Mathew JP, Mackensen GB, Phillips-Bute B, Grocott HP, Glower DD, Laskowitz DT, Blumenthal JA, Newman MF; Neurologic Outcome Research Group (NORG) of the Duke Heart Center. Randomized, double-blinded, placebo controlled study of neuroprotection with lidocaine in cardiac surgery. Stroke. 2009 Mar;40(3):880-7. doi: 10.1161/STROKEAHA.108.531236. Epub 2009 Jan 22. |
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| Background | Mark DB, Nelson C, Delong E, et al. Comparisin of quality of life outcomes following coronary angioplasty, coronary bypass surgery and medicine. J Am Coll Cardiol. 1993; 21:216A |
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| 2782256 | Background | Hlatky MA, Boineau RE, Higginbotham MB, Lee KL, Mark DB, Califf RM, Cobb FR, Pryor DB. A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index). Am J Cardiol. 1989 Sep 15;64(10):651-4. doi: 10.1016/0002-9149(89)90496-7. |
| 3298292 | Background | Ware JE Jr. Standards for validating health measures: definition and content. J Chronic Dis. 1987;40(6):473-80. doi: 10.1016/0021-9681(87)90003-8. |
| 3978515 | Background | Guyatt GH, Sullivan MJ, Thompson PJ, Fallen EL, Pugsley SO, Taylor DW, Berman LB. The 6-minute walk: a new measure of exercise capacity in patients with chronic heart failure. Can Med Assoc J. 1985 Apr 15;132(8):919-23. |
| 7296795 | Background | Goldman L, Hashimoto B, Cook EF, Loscalzo A. Comparative reproducibility and validity of systems for assessing cardiovascular functional class: advantages of a new specific activity scale. Circulation. 1981 Dec;64(6):1227-34. doi: 10.1161/01.cir.64.6.1227. |
| Background | McDowell I, Newell C. Measuring Health: A Guide To Rating Scales And Questionnaires. New York: Oxford University Press; 1987. |
| 7278416 | Background | Bergner M, Bobbitt RA, Carter WB, Gilson BS. The Sickness Impact Profile: development and final revision of a health status measure. Med Care. 1981 Aug;19(8):787-805. doi: 10.1097/00005650-198108000-00001. |
| 2003706 | Background | Wassertheil-Smoller S, Blaufox MD, Oberman A, Davis BR, Swencionis C, Knerr MO, Hawkins CM, Langford HG. Effect of antihypertensives on sexual function and quality of life: the TAIM Study. Ann Intern Med. 1991 Apr 15;114(8):613-20. doi: 10.7326/0003-4819-114-8-613. |
| Background | Cronbach LJ. Essentials of Psycological Testing. New York: Harper and Row; 1970 |
| Background | Benjamini Y, Hochberg Y. Controlling the False Discovery Rate: A Practical and Powerful Approach to Multiple Testing. J R Statist Soc B. 1995;57(1):289-300 |
| 27470233 | Derived | Klinger RY, Cooter M, Berger M, Podgoreanu MV, Stafford-Smith M, Ortel TL, Welsby IJ, Levy JH, Rinder HM, Newman MF, Mathew JP; Neurologic Outcomes Research Group (NORG) of The Duke Heart Center. Effect of intravenous lidocaine on the transcerebral inflammatory response during cardiac surgery: a randomized-controlled trial. Can J Anaesth. 2016 Nov;63(11):1223-32. doi: 10.1007/s12630-016-0704-0. Epub 2016 Jul 28. |
| Withdrawal by Subject |
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| Found to Meet Exclusion Criteria |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Lidocaine |
Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours |
| OG001 | Placebo | Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours |
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| Primary | Count of Participants With a Decline of Greater Than or Equal to One Standard Deviation in One or More of Five Cognitive Domain Scores Reported as a Dichotomous Post-operative Cognitive Deficit (POCD) Outcome | To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline. We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration. Each domain score is normally distributed with a mean of zero. A change score was calculated for each domain by subtracting the baseline from the 6-week score. A dichotomous outcome variable of post-operative cognitive deficit was defined as a decline of ≥1 standard deviation in 1 or more of the 5 domains. | Posted | Count of Participants | Participants | Preoperative to 6 weeks after surgery |
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| Secondary | Transcerebral Activation Gradients of Platelets | Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removalime points and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups | Planned substudy, that was analyzed after 202 enrolled subjects | Posted | Mean | Standard Deviation | Mean linear fluorescence intensity-MLFI | Baseline to 6 hours post cross-clamp removal |
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| Secondary | Transcerebral Activation Gradients of Neutrophils | Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removal and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups | Planned substudy, that was analyzed after 202 enrolled subjects | Posted | Mean | Standard Deviation | Mean linear fluorescence intensity-MLFI | Baseline to 6 hours post cross-clamp removal |
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| Secondary | Transcerebral Activation Gradients of Monocytes | Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removalime points and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups | Planned substudy, that was analyzed after 202 enrolled subjects. | Posted | Mean | Standard Deviation | Mean linear fluorescence intensity-MLFI | Baseline to 6 hours post cross-clamp removal |
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| Secondary | Transcerebral Activation Gradient of Platelet-neutrophil Conjugates | Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removalime points and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups | Planned substudy, that was analyzed after 202 enrolled subjects. | Posted | Mean | Standard Deviation | Mean linear fluorescence intensity-MLFI | Baseline to 6 hours post cross-clamp removal |
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| Secondary | Change in Cognitive Function From Baseline | To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline. We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 5 preoperative domain scores. The cognitive index score has a mean of zero, thus any positive score is above the mean, any negative score is below the mean. A continuous change score was then calculated by subtracting the baseline from the 1 year cognitive index. The resulting outcome measure is unbounded with standard deviation of 0.35. A negative change score indicating decline and a positive score indicating improvement | There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 1 year after surgery |
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| Secondary | Change in Duke Activity Status Index (DASI) | The DASI is a 12-item scale of functional capacity that has been found to correlate well with objective measures of maximal exercise capacity. Items reflect activities of personal care, ambulation, household tasks, sexual function, and recreational activities. Activities done "with no difficulty" receive scores, which are weighted and summed, for a quantitative measure of functional status. Scores range from 0 to 60; a higher-weighted score indicates better function. | Posted | Mean | Standard Deviation | units on a scale | baseline, 6-weeks |
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| Secondary | Change in Duke Activity Status Index (DASI) | The DASI is a 12-item scale of functional capacity that has been found to correlate well with objective measures of maximal exercise capacity. Items reflect activities of personal care, ambulation, household tasks, sexual function, and recreational activities. Activities done "with no difficulty" receive scores, which are weighted and summed, for a quantitative measure of functional status. Scores range from 0 to 60; a higher-weighted score indicates better function. | There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | baseline, 1-year |
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| Secondary | Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS) | The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient). | Posted | Mean | Standard Deviation | units on a scale | baseline, 6-weeks |
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| Secondary | Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS) | The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient). | There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | baseline, 1-year |
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| Secondary | Change in Center for Epidemiological Studies Depression Scale (CES-D) | Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a 20-item self-report examination designed to measure symptoms of depression. Subjects rate the degree to which they have experienced a range of symptoms of depression, such as "I had crying spells" and "I felt lonely." Scores range from 0 to 60, with higher scores indicating greater depressive symptoms. Scores greater than 16 are typically considered indicative of clinically significant depression. | Posted | Mean | Standard Deviation | units on a scale | baseline, 6-weeks |
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| Secondary | Change in Center for Epidemiological Studies Depression Scale (CES-D) | Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a 20-item self-report examination designed to measure symptoms of depression. Subjects rate the degree to which they have experienced a range of symptoms of depression, such as "I had crying spells" and "I felt lonely." Scores range from 0 to 60, with higher scores indicating greater depressive symptoms. Scores greater than 16 are typically considered indicative of clinically significant depression. | There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | baseline, 1-year |
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| Secondary | Change in Spielberger State Anxiety Inventory (STAI) | Spielberger State Anxiety Inventory (STAI): The STAI consists of two 20-item scales that measure anxiety. Representative items include statements such as "I feel nervous" and "I feel worried." These items are rated on a 4-point scale, based on how well they describe the patient's current or typical mood, from "not at all" to "very much so." Scores range from 20 to 80, with higher scores indicating greater anxiety. | Posted | Mean | Standard Deviation | units on a scale | baseline, 6-weeks |
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| Secondary | Change in Spielberger State Anxiety Inventory (STAI) | Spielberger State Anxiety Inventory (STAI): The STAI consists of two 20-item scales that measure anxiety. Representative items include statements such as "I feel nervous" and "I feel worried." These items are rated on a 4-point scale, based on how well they describe the patient's current or typical mood, from "not at all" to "very much so." Scores range from 20 to 80, with higher scores indicating greater anxiety. | There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | baseline, 1-year |
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| Secondary | Change in Symptom Limitations | Symptom limitations: Patients were given a list of eight symptoms and asked to rate the degree to which the symptom limited daily activities. The symptoms were angina, shortness of breath, arthritis, back trouble, leg pains, headaches, fatigue, and other. Scores range from 8 to 32, with higher scores indicating greater limitations. | Posted | Mean | Standard Deviation | units on a scale | baseline, 6-weeks |
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| Secondary | Change in Symptom Limitations | Symptom limitations: Patients were given a list of eight symptoms and asked to rate the degree to which the symptom limited daily activities. The symptoms were angina, shortness of breath, arthritis, back trouble, leg pains, headaches, fatigue, and other. Scores range from 8 to 32, with higher scores indicating greater limitations. | There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | baseline, 1-year |
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| Secondary | Change in the Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL) | Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL): This measure contains six items that assess the ability to perform important tasks for daily living (e.g., "Could you prepare your own meals?" "Could you drive a car?"). Scores range from 6 to 24. Higher scores indicate increasing difficulty in engaging in daily activities. | Posted | Mean | Standard Deviation | units on a scale | baseline, 6-weeks |
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| Secondary | Change in the Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL) | Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL): This measure contains six items that assess the ability to perform important tasks for daily living (e.g., "Could you prepare your own meals?" "Could you drive a car?"). Scores range from 6 to 24. Higher scores indicate increasing difficulty in engaging in daily activities. | There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | baseline, 1-year |
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| Secondary | Change in the Cognitive Difficulties Scale | Cognitive Difficulties Scale: a 39-item scale, is a self-report assessment of perceived problems in long- and short-term memory, concentration, attention, and psycho-motor coordination. Sample items are "I forget errands I planned to do" and "I fail to recognize people I know." Scores range from 39 to 164, with higher scores indicating greater cognitive difficulty. | Posted | Mean | Standard Deviation | units on a scale | baseline, 6-weeks |
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| Secondary | Change in the Cognitive Difficulties Scale | Cognitive Difficulties Scale: a 39-item scale, is a self-report assessment of perceived problems in long- and short-term memory, concentration, attention, and psycho-motor coordination. Sample items are "I forget errands I planned to do" and "I fail to recognize people I know." Scores range from 39 to 164, with higher scores indicating greater cognitive difficulty. | There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | baseline, 1-year |
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| Secondary | Change in Perceived Social Support | Perceived Social Support Scale: Twelve items indicate how strongly subjects agree that there is "a special person who is around when I am in need" and "my family really tries to help me." Choices range from "very strongly disagree" to "very strongly agree." Items are summed for a range of 12 to 84, with a high score meaning more social support. | Posted | Mean | Standard Deviation | units on a scale | baseline, 6-weeks |
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| Secondary | Change in Perceived Social Support | Perceived Social Support Scale: Twelve items indicate how strongly subjects agree that there is "a special person who is around when I am in need" and "my family really tries to help me." Choices range from "very strongly disagree" to "very strongly agree." Items are summed for a range of 12 to 84, with a high score meaning more social support. | There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | baseline, 1-year |
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| Secondary | Change in Social Activity | Social Activity: This measure consisted of eight items that indicate the degree of social interaction. Sample items are "How often do you talk on the telephone with friends and relatives?" and "How often do you attend meetings of social groups, clubs, or civic organizations?" Scores range from 8 to 32. A lower score indicates more social activity. | Posted | Mean | Standard Deviation | units on a scale | baseline, 6-weeks |
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| Secondary | Change in Social Activity | Social Activity: This measure consisted of eight items that indicate the degree of social interaction. Sample items are "How often do you talk on the telephone with friends and relatives?" and "How often do you attend meetings of social groups, clubs, or civic organizations?" Scores range from 8 to 32. A lower score indicates more social activity. | There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | baseline, 1-year |
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| Secondary | Change in Study 36-Item Short Form Health Survey (SF-36) | The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36): The SF-36 was designed to measure general health status. Two scales were used: Work Activities (four items) and General Health (one item). For the work activities scale, the reported score was the sum of four questions, each with values ranging from 1 to 4, the total score could range from 4 to 16. A higher score on Work Activities indicates more health-related problems For the general health question, the patients ranked their health from Excellent (1) to poor (5), the scale ranged from 1 to 5 with 1 being best health and 5 being worst. A high score in General Health indicates poorer health state. | Posted | Mean | Standard Deviation | units on a scale | baseline, 6-weeks |
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| Secondary | Change in Study 36-Item Short Form Health Survey (SF-36) | The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36): The SF-36 was designed to measure general health status. Two scales were used: Work Activities (four items) and General Health (one item). For the work activities scale, the reported score was the sum of four questions, each with values ranging from 1 to 4, the total score could range from 4 to 16. A higher score on Work Activities indicates more health-related problems For the general health question, the patients ranked their health from Excellent (1) to poor (5), the scale ranged from 1 to 5 with 1 being best health and 5 being worst. A high score in General Health indicates poorer health state. | There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | baseline, 1-year |
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| Secondary | Change in Neurological Function, as Measured by the Western Perioperative Neurologic Scale (WPNS) | The Western perioperative neurologic scale was designed to detect neurologic deficits after cardiac surgery. It includes 14 items classified into eight domains (mentation, speech, cranial nerve function, motor weakness, sensation and cerebellum, reflexes, and gait). Each item is scored from 0 (severe deficit) to3 (normal), and a maximum score of 42 indicates normal neurological function. | Posted | Mean | Standard Deviation | units on a scale | baseline, 6-weeks |
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| Secondary | Change in Neurological Function, as Measured by the Western Perioperative Neurologic Scale (WPNS) | The Western perioperative neurologic scale was designed to detect neurologic deficits after cardiac surgery. It includes 14 items classified into eight domains (mentation, speech, cranial nerve function, motor weakness, sensation and cerebellum, reflexes, and gait). Each item is scored from 0 (severe deficit) to3 (normal), and a maximum score of 42 indicates normal neurological function. | There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | baseline, 1-year |
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|
|
| 6 |
| 241 |
| 105 |
| 241 |
| 34 |
| 241 |
| EG001 | Placebo | Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours | 7 | 237 | 103 | 237 | 34 | 237 |
| Acute Urinary Retention | Renal and urinary disorders | Systematic Assessment |
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| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
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| Anaphylatic or Anaphylactoid rxn | Immune system disorders | Systematic Assessment |
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| Aphasia | Nervous system disorders | Systematic Assessment |
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| Atrial Dysrhythmia - Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
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| Atrial Dysrhythmia -Sinus Bradycardia | Cardiac disorders | Systematic Assessment |
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| AV Block | Cardiac disorders | Systematic Assessment |
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| Bacermia/sepsis | Infections and infestations | Systematic Assessment |
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| Bleeding | Blood and lymphatic system disorders | Systematic Assessment |
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| Bradycardia | Cardiac disorders | Systematic Assessment |
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| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cardiac Arrest | Cardiac disorders | Systematic Assessment |
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| Cardiac Tamponade | Cardiac disorders | Systematic Assessment |
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| Cardiogenic Shock | Cardiac disorders | Systematic Assessment |
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| Chylothorax | Blood and lymphatic system disorders | Systematic Assessment |
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| Coagulopathy | Blood and lymphatic system disorders | Systematic Assessment |
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| Complete heart block | Cardiac disorders | Systematic Assessment |
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| Confusion/encephalopathy | Nervous system disorders | Systematic Assessment |
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| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
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| Continuous coma | Nervous system disorders | Systematic Assessment |
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| Deep Vein Thrombosis | Vascular disorders | Systematic Assessment |
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| Diaphragmic tear | Injury, poisoning and procedural complications | Systematic Assessment |
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| Dysphagia | Nervous system disorders | Systematic Assessment |
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| Fever of Non-Specified Origin | Immune system disorders | Systematic Assessment |
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| Fluid overload | General disorders | Systematic Assessment |
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| GI Bleed | Gastrointestinal disorders | Systematic Assessment |
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| Heart attack-hospitalization | Cardiac disorders | Systematic Assessment |
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| Heart failure | Cardiac disorders | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | Systematic Assessment |
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| Hemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hemorrhagic shock | Cardiac disorders | Systematic Assessment |
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| Hemothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Haemophilus Influenzae | Infections and infestations | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypertension | Cardiac disorders | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypotension | Cardiac disorders | Systematic Assessment |
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| Hypothermia | Nervous system disorders | Systematic Assessment |
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| Hypovolemic shock | Cardiac disorders | Systematic Assessment |
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| Hypoxemia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Irritable bowel syndrome | Gastrointestinal disorders | Systematic Assessment |
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| Junctional rhythm | Cardiac disorders | Systematic Assessment |
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| Lactic acidosis | Metabolism and nutrition disorders | Systematic Assessment |
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| Left brachial embolectomy | Surgical and medical procedures | Systematic Assessment |
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| Left bundle branch block | Cardiac disorders | Systematic Assessment |
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| Left pleural effusion thoracentesis | Surgical and medical procedures | Systematic Assessment |
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| Left vocal cord palsy | Nervous system disorders | Systematic Assessment |
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| Leukocytosis | Infections and infestations | Systematic Assessment |
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| LVAD | Surgical and medical procedures | Systematic Assessment |
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| Metabolic acidosis | Metabolism and nutrition disorders | Systematic Assessment |
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| MRSA | Infections and infestations | Systematic Assessment |
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| Nausea/Vomiting/Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Pacemaker Placement | Surgical and medical procedures | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Parkinson's disease | Nervous system disorders | Systematic Assessment |
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| PEA Arrest | Cardiac disorders | Systematic Assessment |
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| Pericarditis | Cardiac disorders | Systematic Assessment |
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| Phlebitis | Immune system disorders | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Prolonged hospitalization | General disorders | Systematic Assessment |
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| Protein malnutrition | Metabolism and nutrition disorders | Systematic Assessment |
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| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary contusion | Injury, poisoning and procedural complications | Systematic Assessment |
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| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulseless electrical activity | Cardiac disorders | Systematic Assessment |
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| re-admission after fall | General disorders | Systematic Assessment |
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| Reexploration For Bleeding | Surgical and medical procedures | Systematic Assessment |
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| Reintubation | Surgical and medical procedures | Systematic Assessment |
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| Renal Failure | Renal and urinary disorders | Systematic Assessment |
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| Renal Insufficiency | Renal and urinary disorders | Systematic Assessment |
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| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Shock | Cardiac disorders | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
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| Sternal Wound Infection | Infections and infestations | Systematic Assessment |
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| Stroke | Vascular disorders | Systematic Assessment |
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| Subcutaneous Air | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Suprapubic catheter placement | Surgical and medical procedures | Systematic Assessment |
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| Syncope | Cardiac disorders | Systematic Assessment |
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| Thoracentesis | Surgical and medical procedures | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Thrush | Infections and infestations | Systematic Assessment |
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| Tranfusion rxn | Immune system disorders | Systematic Assessment |
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| Trifascicular block | Cardiac disorders | Systematic Assessment |
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| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
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| Ventilation > 48hr | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Ventilator associated pneumonia | Infections and infestations | Systematic Assessment |
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| Ventricular Dysrhythmia - Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
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| Ventricular ectopy | Cardiac disorders | Systematic Assessment |
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Not provided
Not provided
| Aniline Compounds |
| D000588 | Amines |
| End of Bypass |
|
| 6 hours post cross-clamp removal |
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| End of Bypass |
|
| 6 hours post cross-clamp removal |
|
| End of Bypass |
|
| 6 hours post cross-clamp removal |
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| End of Bypass |
|
| 6 hours post cross-clamp removal |
|