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| ID | Type | Description | Link |
|---|---|---|---|
| R01GM112871 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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The investigators will recruit and randomize 200 elective cardiac surgery patients to receive physiologic oxygenation (normoxia) or hyper-oxygenation (hyperoxia) during surgery to test the hypothesis that intraoperative physiologic oxygenation decreases the generation of reactive oxygen species, oxidative damage, and postoperative organ injury compared to hyper-oxygenation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normoxia | Experimental | Oxygen administration to maintain a hemoglobin oxygen saturation of 95-97% or arterial PaO2 80-110 mmHg during surgery. |
|
| Hyperoxia | Active Comparator | Fraction of inspired oxygen 1.0 during mechanical ventilation and 0.8 during cardiopulmonary bypass during surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen - normoxia | Drug | Titration of FIO2 to maintain normal hemoglobin oxygen saturation (95-97%) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Systemic Oxidative Damage | quantified by measuring F2-isoprostanes isofurans following separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting | separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention) |
| Acute Kidney Injury | quantified by change in serum creatinine concentration | baseline to postoperative day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Vascular Reactivity / Endothelial Function (as Measured by Flow Mediated Dilation) | brachial artery flow mediated dilation assessed when patient arrives in ICU after surgery. brachial artery flow mediated dilation is represented as the percent change in brachial artery diameter following 5 minutes of artery occlusion. The entire assessment takes place at ICU admission. | ICU admission (immediately after arrival in ICU from operating room) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederic T. Billings, IV, MD, MSc | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40673571 | Derived | Lopez MG, Pandey AK, Hennessy C, Hughes CG, Absi TS, Shah AS, Shotwell MS, Harrison DG, Billings FT 4th; ROCS Trial Investigators. Effects of Oxygen on Perioperative Vascular Function: A Randomized Clinical Trial. J Am Heart Assoc. 2025 Aug 5;14(15):e041778. doi: 10.1161/JAHA.125.041778. Epub 2025 Jul 17. | |
| 39110454 | Derived | Lopez MG, Shotwell MS, Hennessy C, Pretorius M, McIlroy DR, Kimlinger MJ, Mace EH, Absi T, Shah AS, Brown NJ, Billings FT 4th; ROCS trial investigators. Intraoperative Oxygen Treatment, Oxidative Stress, and Organ Injury Following Cardiac Surgery: A Randomized Clinical Trial. JAMA Surg. 2024 Oct 1;159(10):1106-1116. doi: 10.1001/jamasurg.2024.2906. |
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213 patients signed consent. 12 participants were withdrawn prior to randomization. 201 were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Normoxia | Oxygen administration to maintain a hemoglobin oxygen saturation of 95-97% or arterial PaO2 80-110 mmHg during surgery. Oxygen - normoxia: Titration of FIO2 to maintain normal hemoglobin oxygen saturation (95-97%) |
| FG001 | Hyperoxia | Fraction of inspired oxygen 1.0 during mechanical ventilation and 0.8 during cardiopulmonary bypass during surgery. Oxygen - hyperoxia: Administration of 1.0 FIO2 during ventilation and 0.8 or above during cardiopulmonary bypass |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
101 participant were randomly assigned hyperoxia. 1 of these participant's surgery was cancelled, and this participant was therefore withdrawn from the study. We do not have baseline characteristics for this participant.
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| ID | Title | Description |
|---|---|---|
| BG000 | Normoxia | Oxygen administration to maintain a hemoglobin oxygen saturation of 95-97% or arterial PaO2 80-110 mmHg during surgery. Oxygen - normoxia: Titration of FIO2 to maintain normal hemoglobin oxygen saturation (95-97%) |
| BG001 | Hyperoxia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Intraoperative Systemic Oxidative Damage | quantified by measuring F2-isoprostanes isofurans following separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting | Posted | Median | Inter-Quartile Range | pg/ml | separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention) |
|
baseline to one year following surgery
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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 | Normoxia | Oxygen administration to maintain a hemoglobin oxygen saturation of 95-97% or arterial PaO2 80-110 mmHg during surgery. Oxygen - normoxia: Titration of FIO2 to maintain normal hemoglobin oxygen saturation (95-97%) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Category: Arrythmia, Pacemaker or Cardiac Arrest | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | Immune system disorders | Systematic Assessment | Temperature > 38.0 degrees Celsius |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frederic T. BIllings IV | Vanderbilt University | 6159368487 | frederic.t.billings@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 7, 2016 | Jul 11, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D018496 | Hyperoxia |
| D051437 | Renal Insufficiency |
| D003693 | Delirium |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007674 | Kidney Diseases |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| Oxygen - hyperoxia | Drug | Administration of 1.0 FIO2 during ventilation and 0.8 or above during cardiopulmonary bypass |
|
|
| Mitochondrial Function | mitochondrial function in atrial myocardium estimated by quantifying adenylate kinase at the end of surgery and oxygen intervention | up to 2 days following surgery |
| Number of People With Arrhythmia | defined as any atrial fibrillation following surgery until hospital discharge assessed using continuous telemetry, rhythm strips, and electrocardiograms | from surgery to hospital discharge, average of 6 days following surgery |
| Myocardial Injury or Infarction | plasma concentration of creatine kinase, myocardial band | morning of postoperative day 1 |
| Number of People With Stroke | Defined as new deficit on neurologic exam and confirmed with radiologic evidence occurring at any point prior to hospital discharge | from surgery to hospital discharge, average of 6 days following surgery |
| Postoperative Cognitive Dysfunction | Median change scores at the Short Blessed Scale (SBT) administered one-year following surgery. The SBT is a validated rating scale, administered by the clinician, measuring the cognitive performance. Sum Total (range 0-28) with 0 indicating no cognitive impairment and 28 indicating severe cognitive impairment. | up to 18 months following surgery |
| Respiratory Failure | reintubation | from surgery to hospital discharge, average of 6 days following surgery |
| Chronic Kidney Disease | eGFR one year following surgery | 12 months following surgery |
| Inflammation | Estimated by quantifying plasma concentration of plasminogen activator inhibitor-1 (PAI-1) | up to 2 days following surgery |
| Hemolysis | plasma free hemoglobin | separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention) |
| Reactive Oxygen Species Production | TMH electron spin probe | end of surgery, defined as immediately after separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention) |
| Acute Brain Dysfunction (Delirium) | The number of participants with acute brain dysfunction as assessed by the Confusion Assessment Method for the ICU (CAM-ICU) twice daily while patients are in the ICU or for first 3 postoperative days. | from surgery to hospital discharge, average of 6 days following surgery |
| Oxygenation and Perfusion (Lactate) | arterial lactate measured from arterial blood collected at ICU admission (immediately after arrival in ICU from operating room) | ICU admission (immediately after arrival in ICU from operating room) |
| Acute Kidney Injury, According to KDIGO Criteria | KDIGO acute kidney injury is defined as an increase in SCr ≥ 0.3 mg/dL (≥ 26.5 lmol/L) within 48 hours of surgery or 1.5 to 1.9 times baseline within 7 days of surgery | up to 7 days following surgery |
| Acute Kidney Injury Estimated by Urine Concentration of TIMP-2 IGFBP7 | Urinary concentration of [TIMP2]*[IGFBP7] 6 hours after ICU admission | baseline to 2 days following surgery |
| Acute Kidney Injury Estimated by Urine Concentration of NGAL | Urinary concentration of neutrophil gelatinase-associated lipocalin (NGAL) 6 hours after ICU admission. | baseline to 2 days following surgery |
| Reactive Oxygen Species Production | CAT1H electron spin probe | end of surgery, defined as immediately after separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention) |
| Oxygenation and Perfusion (SpO2) | hemoglobin O2 saturation summarized using SpO2 data continuously measured and recorded every minute during surgery. We calculated the median SpO2 throughout surgery using all the minute to minute values. For example, if a participant had a 5 hour (300 minutes) long surgery, the participant would have 300 SpO2 measurements. We calculated and report the median of those measurements. | during surgery |
| Oxygenation and Perfusion (PaO2) | partial pressure of oxygen in arterial blood measured from blood sampled at end of surgery, defined as following separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention) | end of surgery, defined as separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention) |
| Oxygenation and Perfusion (Cerebral Oximetry) | brain hemoglobin oxygenation using near-infrared spectroscopy (NIRS). The median percent changes from baseline (baseline measured at beginning of surgery when probes placed on forehead, prior to intervention) throughout surgery was calculated using cerebral oximetry measurements collected every minute throughout surgery. We calculated the difference between baseline and each measurement throughout surgery. For example, if a participant had a 5 hour (300 minutes) long surgery, the participant would have 300 cerebral oximetry measurements. We calculated and report the median of those measurements. | continuously assessed throughout surgery and recorded each minute |
| Oxygenation and Perfusion (SvO2) | mixed venous O2 saturation, measured from blood sampled from pulmonary artery sampled at end of surgery, defined as following separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention) | end of surgery, defined as following separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention) |
| Oxygenation and Perfusion (Cardiac Index) | cardiac output (normalized to body surface area, i.e., cardiac index) | end of surgery, defined as immediately after separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention) |
| Vascular Reactivity / Endothelial Function (Peripheral Artery Tonometry) | reactive hyperemia index measured at ICU admission (immediately after arrival in ICU from operating room). The reactive hyperemia index is a number generated by an endopat machine performing peripheral artery tonometry. The index ranges from approximately 1-3, where higher values indicate better vascular reactivity and endothelial function. | ICU admission (immediately after arrival in ICU from operating room) |
| Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Dependent Vasodilation, EC50) | Effective concentration for 50% dilation acetylcholine dose response, tension wire myography from arterioles dissected from epicardial fat | tissue collected during surgery when heart is exposed approximately 2 hours into intervention |
| Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Dependent Vasodilation, Emax) | Maximum percentage of arteriole dilation after increasing doses of acetylcholine measured using tension wire myography of arterioles dissected from epicardial fat. The fat sample was collected during surgery when heart is exposed approximately 2 hours into intervention. | tissue collected during surgery when heart is exposed approximately 2 hours into intervention |
| Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Independent Vasodilation, EC50) | Effective concentration for 50% dilation sodium nitroprusside dose response, tension wire myography from arterioles dissected from epicardial fat | tissue collected during surgery when heart is exposed approximately 2 hours into intervention |
| Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Independent Vasodilation, Emax) | Maximum percentage of arteriole dilation after increasing doses of sodium nitroprusside measured using tension wire myography of arterioles dissected from epicardial fat. The fat sample was collected during surgery when heart is exposed approximately 2 hours into intervention. | tissue collected during surgery when heart is exposed approximately 2 hours into intervention |
| Vascular Reactivity / Endothelial Function (Tension Wire Myography, sGC Activation Vasodilation, EC50) | Effective concentration for 50% dilation cinaciguat dose response, tension wire myography from arterioles dissected from epicardial fat | tissue collected during surgery when heart is exposed approximately 2 hours into intervention |
| Vascular Reactivity / Endothelial Function (Tension Wire Myography, sGC Activation Vasodilation, Emax) | Maximum percentage of arteriole dilation after increasing doses of cinaciguat measured using tension wire myography of arterioles dissected from epicardial fat. The fat sample was collected during surgery when heart is exposed approximately 2 hours into intervention. | tissue collected during surgery when heart is exposed approximately 2 hours into intervention |
| Vascular Reactivity / Endothelial Function (PAI-1) | Plasminogen activator inhibitor 1 | end of surgery, defined as immediately after separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention) |
| Vascular Reactivity / Endothelial Function (E-selectin) | E-selectin | end of surgery, defined as immediately after separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention) |
| 28651648 | Derived | Lopez MG, Pretorius M, Shotwell MS, Deegan R, Eagle SS, Bennett JM, Sileshi B, Liang Y, Gelfand BJ, Kingeter AJ, Siegrist KK, Lombard FW, Richburg TM, Fornero DA, Shaw AD, Hernandez A, Billings FT 4th. The Risk of Oxygen during Cardiac Surgery (ROCS) trial: study protocol for a randomized clinical trial. Trials. 2017 Jun 26;18(1):295. doi: 10.1186/s13063-017-2021-5. |
Fraction of inspired oxygen 1.0 during mechanical ventilation and 0.8 during cardiopulmonary bypass during surgery. Oxygen - hyperoxia: Administration of 1.0 FIO2 during ventilation and 0.8 or above during cardiopulmonary bypass |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Serum Creatinine | Median | Inter-Quartile Range | mg/dl |
|
|
|
| Primary | Acute Kidney Injury | quantified by change in serum creatinine concentration | Posted | Median | Inter-Quartile Range | mg/dl | baseline to postoperative day 2 |
|
|
|
| Secondary | Vascular Reactivity / Endothelial Function (as Measured by Flow Mediated Dilation) | brachial artery flow mediated dilation assessed when patient arrives in ICU after surgery. brachial artery flow mediated dilation is represented as the percent change in brachial artery diameter following 5 minutes of artery occlusion. The entire assessment takes place at ICU admission. | Posted | Median | Inter-Quartile Range | percentage change | ICU admission (immediately after arrival in ICU from operating room) |
|
|
|
| Secondary | Mitochondrial Function | mitochondrial function in atrial myocardium estimated by quantifying adenylate kinase at the end of surgery and oxygen intervention | Analyzed in subjects with tissue available | Posted | Median | Inter-Quartile Range | Absorbance Units (AU) | up to 2 days following surgery |
|
|
|
| Secondary | Number of People With Arrhythmia | defined as any atrial fibrillation following surgery until hospital discharge assessed using continuous telemetry, rhythm strips, and electrocardiograms | Posted | Count of Participants | Participants | from surgery to hospital discharge, average of 6 days following surgery |
|
|
|
| Secondary | Myocardial Injury or Infarction | plasma concentration of creatine kinase, myocardial band | Posted | Median | Inter-Quartile Range | ng/ml | morning of postoperative day 1 |
|
|
|
| Secondary | Number of People With Stroke | Defined as new deficit on neurologic exam and confirmed with radiologic evidence occurring at any point prior to hospital discharge | Posted | Count of Participants | Participants | from surgery to hospital discharge, average of 6 days following surgery |
|
|
|
| Secondary | Postoperative Cognitive Dysfunction | Median change scores at the Short Blessed Scale (SBT) administered one-year following surgery. The SBT is a validated rating scale, administered by the clinician, measuring the cognitive performance. Sum Total (range 0-28) with 0 indicating no cognitive impairment and 28 indicating severe cognitive impairment. | Assessed in participants available for long-term follow-up who were able to complete cognitive assessments | Posted | Median | Inter-Quartile Range | score on a scale | up to 18 months following surgery |
|
|
|
| Secondary | Respiratory Failure | reintubation | Posted | Count of Participants | Participants | from surgery to hospital discharge, average of 6 days following surgery |
|
|
|
| Secondary | Chronic Kidney Disease | eGFR one year following surgery | eGFR assessed in participants available for long-term follow-up | Posted | Median | Inter-Quartile Range | ml/min/1.73 meters squared | 12 months following surgery |
|
|
|
| Secondary | Inflammation | Estimated by quantifying plasma concentration of plasminogen activator inhibitor-1 (PAI-1) | Posted | Median | Inter-Quartile Range | ng/ml | up to 2 days following surgery |
|
|
|
| Secondary | Hemolysis | plasma free hemoglobin | Posted | Median | Inter-Quartile Range | ng/ml | separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention) |
|
|
|
| Secondary | Reactive Oxygen Species Production | TMH electron spin probe | Posted | Median | Inter-Quartile Range | Absorbance Units (AU) | end of surgery, defined as immediately after separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention) |
|
|
|
| Secondary | Acute Brain Dysfunction (Delirium) | The number of participants with acute brain dysfunction as assessed by the Confusion Assessment Method for the ICU (CAM-ICU) twice daily while patients are in the ICU or for first 3 postoperative days. | Posted | Count of Participants | Participants | from surgery to hospital discharge, average of 6 days following surgery |
|
|
|
| Secondary | Oxygenation and Perfusion (Lactate) | arterial lactate measured from arterial blood collected at ICU admission (immediately after arrival in ICU from operating room) | Posted | Median | Inter-Quartile Range | mmol/liter | ICU admission (immediately after arrival in ICU from operating room) |
|
|
|
| Secondary | Acute Kidney Injury, According to KDIGO Criteria | KDIGO acute kidney injury is defined as an increase in SCr ≥ 0.3 mg/dL (≥ 26.5 lmol/L) within 48 hours of surgery or 1.5 to 1.9 times baseline within 7 days of surgery | Posted | Count of Participants | Participants | up to 7 days following surgery |
|
|
|
| Secondary | Acute Kidney Injury Estimated by Urine Concentration of TIMP-2 IGFBP7 | Urinary concentration of [TIMP2]*[IGFBP7] 6 hours after ICU admission | Posted | Median | Inter-Quartile Range | (ng/ml) squared | baseline to 2 days following surgery |
|
|
|
| Secondary | Acute Kidney Injury Estimated by Urine Concentration of NGAL | Urinary concentration of neutrophil gelatinase-associated lipocalin (NGAL) 6 hours after ICU admission. | Posted | Median | Inter-Quartile Range | ng/ml | baseline to 2 days following surgery |
|
|
|
| Secondary | Reactive Oxygen Species Production | CAT1H electron spin probe | Posted | Median | Inter-Quartile Range | Absorbance Units (AU) | end of surgery, defined as immediately after separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention) |
|
|
|
| Secondary | Oxygenation and Perfusion (SpO2) | hemoglobin O2 saturation summarized using SpO2 data continuously measured and recorded every minute during surgery. We calculated the median SpO2 throughout surgery using all the minute to minute values. For example, if a participant had a 5 hour (300 minutes) long surgery, the participant would have 300 SpO2 measurements. We calculated and report the median of those measurements. | Posted | Median | Inter-Quartile Range | percent saturation | during surgery |
|
|
|
| Secondary | Oxygenation and Perfusion (PaO2) | partial pressure of oxygen in arterial blood measured from blood sampled at end of surgery, defined as following separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention) | Posted | Median | Inter-Quartile Range | mmHg | end of surgery, defined as separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention) |
|
|
|
| Secondary | Oxygenation and Perfusion (Cerebral Oximetry) | brain hemoglobin oxygenation using near-infrared spectroscopy (NIRS). The median percent changes from baseline (baseline measured at beginning of surgery when probes placed on forehead, prior to intervention) throughout surgery was calculated using cerebral oximetry measurements collected every minute throughout surgery. We calculated the difference between baseline and each measurement throughout surgery. For example, if a participant had a 5 hour (300 minutes) long surgery, the participant would have 300 cerebral oximetry measurements. We calculated and report the median of those measurements. | Posted | Median | Inter-Quartile Range | percentage change from baseline | continuously assessed throughout surgery and recorded each minute |
|
|
|
| Secondary | Oxygenation and Perfusion (SvO2) | mixed venous O2 saturation, measured from blood sampled from pulmonary artery sampled at end of surgery, defined as following separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention) | Posted | Median | Inter-Quartile Range | percent saturation | end of surgery, defined as following separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention) |
|
|
|
| Secondary | Oxygenation and Perfusion (Cardiac Index) | cardiac output (normalized to body surface area, i.e., cardiac index) | Posted | Median | Inter-Quartile Range | liters/min/meter squared | end of surgery, defined as immediately after separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention) |
|
|
|
| Secondary | Vascular Reactivity / Endothelial Function (Peripheral Artery Tonometry) | reactive hyperemia index measured at ICU admission (immediately after arrival in ICU from operating room). The reactive hyperemia index is a number generated by an endopat machine performing peripheral artery tonometry. The index ranges from approximately 1-3, where higher values indicate better vascular reactivity and endothelial function. | Posted | Median | Inter-Quartile Range | index | ICU admission (immediately after arrival in ICU from operating room) |
|
|
|
| Secondary | Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Dependent Vasodilation, EC50) | Effective concentration for 50% dilation acetylcholine dose response, tension wire myography from arterioles dissected from epicardial fat | Posted | Mean | 95% Confidence Interval | log Molar | tissue collected during surgery when heart is exposed approximately 2 hours into intervention |
|
|
|
| Secondary | Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Dependent Vasodilation, Emax) | Maximum percentage of arteriole dilation after increasing doses of acetylcholine measured using tension wire myography of arterioles dissected from epicardial fat. The fat sample was collected during surgery when heart is exposed approximately 2 hours into intervention. | Posted | Mean | 95% Confidence Interval | percent relaxation | tissue collected during surgery when heart is exposed approximately 2 hours into intervention |
|
|
|
| Secondary | Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Independent Vasodilation, EC50) | Effective concentration for 50% dilation sodium nitroprusside dose response, tension wire myography from arterioles dissected from epicardial fat | Posted | Mean | 95% Confidence Interval | log Molar | tissue collected during surgery when heart is exposed approximately 2 hours into intervention |
|
|
|
| Secondary | Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Independent Vasodilation, Emax) | Maximum percentage of arteriole dilation after increasing doses of sodium nitroprusside measured using tension wire myography of arterioles dissected from epicardial fat. The fat sample was collected during surgery when heart is exposed approximately 2 hours into intervention. | Posted | Mean | 95% Confidence Interval | percent relaxation | tissue collected during surgery when heart is exposed approximately 2 hours into intervention |
|
|
|
| Secondary | Vascular Reactivity / Endothelial Function (Tension Wire Myography, sGC Activation Vasodilation, EC50) | Effective concentration for 50% dilation cinaciguat dose response, tension wire myography from arterioles dissected from epicardial fat | Posted | Mean | 95% Confidence Interval | log Molar | tissue collected during surgery when heart is exposed approximately 2 hours into intervention |
|
|
|
| Secondary | Vascular Reactivity / Endothelial Function (Tension Wire Myography, sGC Activation Vasodilation, Emax) | Maximum percentage of arteriole dilation after increasing doses of cinaciguat measured using tension wire myography of arterioles dissected from epicardial fat. The fat sample was collected during surgery when heart is exposed approximately 2 hours into intervention. | Posted | Mean | 95% Confidence Interval | percent relaxation | tissue collected during surgery when heart is exposed approximately 2 hours into intervention |
|
|
|
| Secondary | Vascular Reactivity / Endothelial Function (PAI-1) | Plasminogen activator inhibitor 1 | Posted | Median | Inter-Quartile Range | ng/ml | end of surgery, defined as immediately after separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention) |
|
|
|
| Secondary | Vascular Reactivity / Endothelial Function (E-selectin) | E-selectin | Posted | Median | Inter-Quartile Range | ng/ml | end of surgery, defined as immediately after separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention) |
|
|
|
| 2 |
| 100 |
| 8 |
| 100 |
| 80 |
| 100 |
| EG001 | Hyperoxia | Fraction of inspired oxygen 1.0 during mechanical ventilation and 0.8 during cardiopulmonary bypass during surgery. Oxygen - hyperoxia: Administration of 1.0 FIO2 during ventilation and 0.8 or above during cardiopulmonary bypass | 0 | 100 | 11 | 100 | 80 | 100 |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | refractory postoperative hypoxia requiring ECMO. |
|
| right ventricular failure | Cardiac disorders | Systematic Assessment |
|
| heparin-induced thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| anaphylaxis | Immune system disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Re-accumulation of moderate to large pleural effusion requiring reinsertion of chest tube |
|
| Seizure | Nervous system disorders | Systematic Assessment |
|
| Surgical complications requiring valve replacement revision | Surgical and medical procedures | Systematic Assessment |
|
| Severe postoperative hallucinations | Psychiatric disorders | Systematic Assessment | 4-5 days of vivid dreams and visual and auditory hallucinations |
|
| Tachycardia | Cardiac disorders | Systematic Assessment | Heart rate > 120 bpm |
|
| Hypotension | Vascular disorders | Systematic Assessment | Mean arterial blood pressure < 60 mmHg |
|
| Vasoplegia | Vascular disorders | Systematic Assessment | Norepinephrine dose > 5 ug/min |
|
| Decreased cardiac output | Cardiac disorders | Systematic Assessment | Cardiac index < 2.0 L/min/m2 |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment | Hematocrit < 30% |
|
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment | White blood cell count > 15,000 |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment | Platelet count < 50,000 |
|
Not provided
Not provided
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |