Trials / Completed
CompletedNCT02361944
Risk of Oxygen During Cardiac Surgery Trial
Risk of Oxygen During Cardiac Surgery (ROCS) Trial
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 213 (actual)
- Sponsor
- Vanderbilt University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oxygen - normoxia | Titration of FIO2 to maintain normal hemoglobin oxygen saturation (95-97%) |
| DRUG | Oxygen - hyperoxia | Administration of 1.0 FIO2 during ventilation and 0.8 or above during cardiopulmonary bypass |
Timeline
- Start date
- 2016-04-05
- Primary completion
- 2020-10-08
- Completion
- 2021-01-08
- First posted
- 2015-02-12
- Last updated
- 2024-02-01
- Results posted
- 2023-08-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02361944. Inclusion in this directory is not an endorsement.