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Risk of Oxygen During Cardiac Surgery Trial
Phase 2, PHASE3 trial testing Oxygen - normoxia in Cardiac Surgery in 213 participants. Completed in 8 January 2021.
| Lead sponsor | Vanderbilt University |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 213 |
| Start date | 5 April 2016 |
| Primary completion | 8 October 2020 |
| Estimated completion | 8 January 2021 |
| Sites | 1 location across United States |
Vanderbilt University
18 and older, any sex, with Cardiac Surgery. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
quantified by measuring F2-isoprostanes isofurans following separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting
| Group | Value | 95% CI |
|---|---|---|
| Normoxia | 69 | 54 – 89 |
| Hyperoxia | 83 | 62 – 108 |
quantified by change in serum creatinine concentration
| Group | Value | 95% CI |
|---|---|---|
| Normoxia | -0.01 | -0.16 – 0.19 |
| Hyperoxia | 0.01 | -0.12 – 0.19 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Normoxia | 4.50 | 1.22 – 8.12 |
| Hyperoxia | 4.71 | 1.80 – 9.68 |
mitochondrial function in atrial myocardium estimated by quantifying adenylate kinase at the end of surgery and oxygen intervention
| Group | Value | 95% CI |
|---|---|---|
| Normoxia | 1884 | 1745 – 2236 |
| Hyperoxia | 1936 | 1591 – 2078 |
defined as any atrial fibrillation following surgery until hospital discharge assessed using continuous telemetry, rhythm strips, and electrocardiograms
| Group | Value | 95% CI |
|---|---|---|
| Normoxia | 37 | |
| Hyperoxia | 46 |
plasma concentration of creatine kinase, myocardial band
| Group | Value | 95% CI |
|---|---|---|
| Normoxia | 27.2 | 11.5 – 58.3 |
| Hyperoxia | 24.5 | 13.4 – 40.8 |
Defined as new deficit on neurologic exam and confirmed with radiologic evidence occurring at any point prior to hospital discharge
| Group | Value | 95% CI |
|---|---|---|
| Normoxia | 1 | |
| Hyperoxia | 2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Normoxia | 3 | 0 – 6 |
| Hyperoxia | 2 | 0 – 4 |
reintubation
| Group | Value | 95% CI |
|---|---|---|
| Normoxia | 5 | |
| Hyperoxia | 1 |
eGFR one year following surgery
| Group | Value | 95% CI |
|---|---|---|
| Normoxia | 63.0 | 50.8 – 84.8 |
| Hyperoxia | 60.4 | 44.3 – 84.4 |
Estimated by quantifying plasma concentration of plasminogen activator inhibitor-1 (PAI-1)
| Group | Value | 95% CI |
|---|---|---|
| Normoxia | 31.08 | 25.23 – 40.08 |
| Hyperoxia | 36.62 | 27.54 – 44.93 |
plasma free hemoglobin
| Group | Value | 95% CI |
|---|---|---|
| Normoxia | 388,030 | 92,628 – 820,820 |
| Hyperoxia | 433,274 | 74,034 – 982,853 |
Time frame: baseline to one year following surgery. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Normoxia | Hyperoxia |
|---|---|---|---|
| Category: Arrythmia, Pacemaker or Cardiac Arrest | Cardiac disorders | — | — |
| Seizure | Nervous system disorders | — | — |
| Surgical complications requiring valve replacement revision | Surgical and medical procedures | — | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — | — |
| right ventricular failure | Cardiac disorders | — | — |
| heparin-induced thrombocytopenia | Blood and lymphatic system disorders | — | — |
| anaphylaxis | Immune system disorders | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — |
| Severe postoperative hallucinations | Psychiatric disorders | — | — |
| Reaction | System | Normoxia | Hyperoxia |
|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | — | — |
| Leukocytosis | Blood and lymphatic system disorders | — | — |
| Vasoplegia | Vascular disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Fever | Immune system disorders | — | — |
| Tachycardia | Cardiac disorders | — | — |
| Decreased cardiac output | Cardiac disorders | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — |
Most-reported serious reactions: Category: Arrythmia, Pacemaker or Cardiac Arrest, Seizure, Surgical complications requiring valve replacement revision, Hypoxia, right ventricular failure, heparin-induced thrombocytopenia, anaphylaxis, Pleural effusion.
Data from ClinicalTrials.gov NCT02361944 adverse events section.
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.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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