Phase 3
Completed N=201
Risk of Oxygen During Cardiac Surgery Trial
Source: ClinicalTrials.gov NCT02361944 ↗Enrolled (actual)
201
Serious AEs
9.5%
Results posted
Aug 2023
Primary outcomePrimary: Intraoperative Systemic Oxidative Damage — 69; 83 pg/ml
◆ Published Evidence
Established
25citations · ~3 / year
The Risk of Oxygen during Cardiac Surgery (ROCS) trial: study protocol for a randomized clinical trial.
Summary
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.
Linked Publications (3)
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The Risk of Oxygen during Cardiac Surgery (ROCS) trial: study protocol for a randomized clinical trial.
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Intraoperative Oxygen Treatment, Oxidative Stress, and Organ Injury Following Cardiac Surgery: A Randomized Clinical Trial.
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Effects of Oxygen on Perioperative Vascular Function: A Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraoperative Systemic Oxidative Damage |
69; 83 | — |
| PRIMARY Acute Kidney Injury |
-0.01; 0.01 | — |
| SECONDARY Vascular Reactivity / Endothelial Function (as Measured by Flow Mediated Dilation) |
4.50; 4.71 | — |
| SECONDARY Mitochondrial Function |
1884; 1936 | — |
| SECONDARY Number of People With Arrhythmia |
37; 46 | — |
| SECONDARY Myocardial Injury or Infarction |
27.2; 24.5 | — |
| SECONDARY Number of People With Stroke |
1; 2 | — |
| SECONDARY Postoperative Cognitive Dysfunction |
3; 2 | — |
| SECONDARY Respiratory Failure |
5; 1 | — |
| SECONDARY Chronic Kidney Disease |
63.0; 60.4 | — |
| SECONDARY Inflammation |
31.08; 36.62 | — |
| SECONDARY Hemolysis |
388,030; 433,274 | — |
| SECONDARY Reactive Oxygen Species Production |
17,300; 17,040 | — |
| SECONDARY Acute Brain Dysfunction (Delirium) |
16; 22 | — |
| SECONDARY Oxygenation and Perfusion (Lactate) |
1.5; 1.8 | — |
| SECONDARY Acute Kidney Injury, According to KDIGO Criteria |
21; 21 | — |
| SECONDARY Acute Kidney Injury Estimated by Urine Concentration of TIMP-2 IGFBP7 |
0.224; 0.187 | — |
| SECONDARY Acute Kidney Injury Estimated by Urine Concentration of NGAL |
6.9; 4.8 | — |
| SECONDARY Oxygenation and Perfusion (SpO2) |
97; 100 | — |
| SECONDARY Oxygenation and Perfusion (PaO2) |
99; 377 | — |
| SECONDARY Oxygenation and Perfusion (Cerebral Oximetry) |
-7.2; 6.0 | — |
| SECONDARY Oxygenation and Perfusion (SvO2) |
68; 78 | — |
| SECONDARY Oxygenation and Perfusion (Cardiac Index) |
2.56; 2.48 | — |
| SECONDARY Vascular Reactivity / Endothelial Function (Peripheral Artery Tonometry) |
1.41; 1.23 | — |
| SECONDARY Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Dependent Vasodilation, EC50) |
-6.13; -5.92 | — |
| SECONDARY Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Dependent Vasodilation, Emax) |
36.2; 39.5 | — |
| SECONDARY Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Independent Vasodilation, EC50) |
-6.95; -5.75 | — |
| SECONDARY Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Independent Vasodilation, Emax) |
91.5; 92.6 | — |
| SECONDARY Vascular Reactivity / Endothelial Function (Tension Wire Myography, sGC Activation Vasodilation, EC50) |
-6.89; -6.66 | — |
| SECONDARY Vascular Reactivity / Endothelial Function (Tension Wire Myography, sGC Activation Vasodilation, Emax) |
97.1; 96.0 | — |
| SECONDARY Vascular Reactivity / Endothelial Function (PAI-1) |
31.2; 36.6 | — |
| SECONDARY Vascular Reactivity / Endothelial Function (E-selectin) |
16.4; 16.2 | — |
Eligibility Criteria
Inclusion Criteria
- Open-heart cardiac surgery, defined as surgery on the heart or aorta that requires sternotomy or thoracotomy.
Exclusion Criteria
- Current acute coronary syndrome (defined as ST elevation myocardial infarction or non-ST elevation myocardial infarction (troponin leak within 72 hours of surgery or consent +/- EKG changes consistent with myocardial ischemia)).
- Home supplemental oxygen use.
- Preoperative supplemental oxygen requirement to maintain arterial O2 sat of 92%.
- Right to left intracardiac shunt including atrial septal defect and ventricular septal defect with Cor Pulmonale.
- Carotid stenosis defined as >50% stenosis.
- Cardiac surgery that requires intraoperative circulatory arrest, such as aortic arch replacement.
- Current use of hemo- or peritoneal dialysis.
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT02361944) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.