Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| 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 |
separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention) |
|
| Primary |
Acute Kidney Injury |
quantified by change in serum creatinine concentration |
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. |
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 |
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 |
from surgery to hospital discharge, average of 6 days following surgery |
|
| Secondary |
Myocardial Injury or Infarction |
plasma concentration of creatine kinase, myocardial band |
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 |
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. |
up to 18 months following surgery |
|
| Secondary |
Respiratory Failure |
reintubation |
from surgery to hospital discharge, average of 6 days following surgery |
|
| Secondary |
Chronic Kidney Disease |
eGFR one year following surgery |
12 months following surgery |
|
| Secondary |
Inflammation |
Estimated by quantifying plasma concentration of plasminogen activator inhibitor-1 (PAI-1) |
up to 2 days following surgery |
|
| Secondary |
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) |
|
| Secondary |
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) |
|
| 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. |
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) |
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 |
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 |
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. |
baseline to 2 days following surgery |
|
| Secondary |
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) |
|
| 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. |
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) |
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. |
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) |
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) |
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. |
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 |
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. |
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 |
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. |
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 |
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. |
tissue collected during surgery when heart is exposed approximately 2 hours into intervention |
|
| Secondary |
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) |
|
| Secondary |
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) |
|
