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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL069081 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
The purpose of this study is to examine the effects of supplemental magnesium on the neurocognitive function of individuals undergoing coronary artery bypass graft (CABG) surgery.
BACKGROUND:
Approximately 400,000 individuals undergo heart operations each year and cognitive impairment occurs frequently following surgery. An increasing number of these individuals are elderly and are particularly susceptible to cognitive dysfunction following surgery. Cognitive impairment is most notable in the early stages following heart surgery, but it may persist in some individuals. While many people think cognitive impairment is subtle, transient, or subclinical, perioperative decline is associated with 5-year cognitive deterioration and reduced quality of life. Multiple strategies, both clinical and pharmacological, have been proposed to reduce the central nervous system dysfunction associated with heart surgery. However, most strategies have been unsuccessful, met with limited success, or are unrealistic from a cost or risk-benefit ratio for the majority of people. This study will examine the effectiveness of supplemental magnesium at preventing the cognitive decline associated with heart surgery.
DESIGN NARRATIVE:
This study will examine the effect of supplemental magnesium on the neurocognitive function of individuals undergoing CABG surgery. The two hypotheses to be tested include the following: 1) therapeutic levels of magnesium reduce post-operative neurocognitive dysfunction after heart surgery; and 2) therapeutic magnesium levels protect quality of life through reduced cognitive dysfunction after heart surgery. This double-blind study will enroll 400 individuals and randomly assign them to either the treatment group, which will receive 100 mg/kg of magnesium, or to the control group. Anesthesia management will be standardized to minimize any impact that anesthesia may have on neurologic or neuropsychologic outcome. Neurocognitive testing will be conducted prior to surgery, and 6 weeks and 1 year following surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium | Active Comparator | 100 mg/kg magnesium |
|
| 0.9 % saline | Placebo Comparator | 100 mg/kg 0.9 % saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium | Drug | 100 mg/kg |
| |
| 0.9% saline |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Function | To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the cognitive test scores from baseline. We chose a four-factor solution, which represents 4 cognitive domains: verbal memory, abstraction and visuo-spatial orientation (executive function), visual memory and attention and concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 4 preoperative domain scores. The cognitive index score has a mean of zero and standard deviation of 0.5. Thus, any positive score is above the mean, any negative score is below the mean, and a score of 0.5 represents 1 SD above the mean. A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index. Negative scores indicate decline and positive scores indicate improvement. | Measured at baseline and 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark F. Newman, MD | Duke University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24105697 | Derived | Mathew JP, White WD, Schinderle DB, Podgoreanu MV, Berger M, Milano CA, Laskowitz DT, Stafford-Smith M, Blumenthal JA, Newman MF; Neurologic Outcome Research Group (NORG) of The Duke Heart Center. Intraoperative magnesium administration does not improve neurocognitive function after cardiac surgery. Stroke. 2013 Dec;44(12):3407-13. doi: 10.1161/STROKEAHA.113.002703. Epub 2013 Oct 8. |
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Hospital and preoperative clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Magnesium | 100 mg/kg magnesium |
| FG001 | 0.9 % Saline | 100 mg/kg 0.9 % saline |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Magnesium | 100 mg/kg magnesium |
| BG001 | 0.9 % Saline | 100 mg/kg 0.9 % saline |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Cognitive Function | To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the cognitive test scores from baseline. We chose a four-factor solution, which represents 4 cognitive domains: verbal memory, abstraction and visuo-spatial orientation (executive function), visual memory and attention and concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 4 preoperative domain scores. The cognitive index score has a mean of zero and standard deviation of 0.5. Thus, any positive score is above the mean, any negative score is below the mean, and a score of 0.5 represents 1 SD above the mean. A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index. Negative scores indicate decline and positive scores indicate improvement. | Posted | Mean | Standard Deviation | Continuous cognitive change score | Measured at baseline and 6 weeks |
|
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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 | Magnesium | 100 mg/kg magnesium |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | Immune system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal Insufficiency | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark F. Newman | Duke University | 919-681-6646 | newma005@mc.duke.edu |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D008274 | Magnesium |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
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| Drug |
Placebo |
|
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
100 mg/kg magnesium |
| OG001 | 0.9 % Saline | 100 mg/kg 0.9 % saline |
|
|
| 37 |
| 198 |
| 137 |
| 198 |
| EG001 | 0.9 % Saline | 100 mg/kg 0.9 % saline | 32 | 191 | 109 | 191 |
| Atrial fibrillation | Cardiac disorders |
|
| Ventricular tachycardia | Cardiac disorders |
|
| Pacemaker placement | Cardiac disorders |
|
| Cardiac arrest | Cardiac disorders |
|
| Myocardial infarction | Cardiac disorders |
|
| Congestive heart failure | Cardiac disorders |
|
| Hypotension | Cardiac disorders |
|
| Cardiac death | Cardiac disorders |
|
| GI bleed | Gastrointestinal disorders |
|
| Small bowel obstruction | Gastrointestinal disorders |
|
| Urinary tract infection | Infections and infestations |
|
| Bleeding | Blood and lymphatic system disorders |
|
| Reexploration for bleeding | Surgical and medical procedures |
|
| Sternal wound infection | Infections and infestations |
|
| Stroke | Nervous system disorders |
|
| Cellulitis | Infections and infestations |
|
| Pneumonia | Infections and infestations |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders |
|
| Renal insufficiency | Renal and urinary disorders |
|
| Renal failure | Renal and urinary disorders |
|
| Postoperative bleeding | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hypotension | Cardiac disorders |
|
| Anemia | Cardiac disorders |
|
| Atrial fibrillation | Cardiac disorders |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D008670 |
| Metals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |