Trial · NCT02361944
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intraoperative Systemic Oxidative Damage | separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention) | quantified by measuring F2-isoprostanes isofurans following separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting |
| Primary | Acute Kidney Injury | baseline to postoperative day 2 | quantified by change in serum creatinine concentration |
| Secondary | Vascular Reactivity / Endothelial Function (as Measured by Flow Mediated Dilation) | ICU admission (immediately after arrival in ICU from operating room) | 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. |
| Secondary | Mitochondrial Function | up to 2 days following surgery | mitochondrial function in atrial myocardium estimated by quantifying adenylate kinase at the end of surgery and oxygen intervention |
| Secondary | Number of People With Arrhythmia | from surgery to hospital discharge, average of 6 days following surgery | defined as any atrial fibrillation following surgery until hospital discharge assessed using continuous telemetry, rhythm strips, and electrocardiograms |
| Secondary | Myocardial Injury or Infarction | morning of postoperative day 1 | plasma concentration of creatine kinase, myocardial band |
| Secondary | Number of People With Stroke | from surgery to hospital discharge, average of 6 days following surgery | Defined as new deficit on neurologic exam and confirmed with radiologic evidence occurring at any point prior to hospital discharge |
| Secondary | Postoperative Cognitive Dysfunction | up to 18 months following surgery | 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. |
| Secondary | Respiratory Failure | from surgery to hospital discharge, average of 6 days following surgery | reintubation |
| Secondary | Chronic Kidney Disease | 12 months following surgery | eGFR one year following surgery |
| Secondary | Inflammation | up to 2 days following surgery | Estimated by quantifying plasma concentration of plasminogen activator inhibitor-1 (PAI-1) |
| Secondary | Hemolysis | separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention) | plasma free hemoglobin |
| Secondary | Reactive Oxygen Species Production | 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) | TMH electron spin probe |
| Secondary | Acute Brain Dysfunction (Delirium) | from surgery to hospital discharge, average of 6 days following surgery | 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. |
| Secondary | Oxygenation and Perfusion (Lactate) | ICU admission (immediately after arrival in ICU from operating room) | arterial lactate measured from arterial blood collected at ICU admission (immediately after arrival in ICU from operating room) |
| Secondary | Acute Kidney Injury, According to KDIGO Criteria | up to 7 days following surgery | 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 |
| Secondary | Acute Kidney Injury Estimated by Urine Concentration of TIMP-2 IGFBP7 | baseline to 2 days following surgery | Urinary concentration of \[TIMP2\]\*\[IGFBP7\] 6 hours after ICU admission |
| Secondary | Acute Kidney Injury Estimated by Urine Concentration of NGAL | baseline to 2 days following surgery | Urinary concentration of neutrophil gelatinase-associated lipocalin (NGAL) 6 hours after ICU admission. |
| Secondary | Reactive Oxygen Species Production | 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) | CAT1H electron spin probe |
| Secondary | Oxygenation and Perfusion (SpO2) | during surgery | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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