CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 213 enrolled
Drug / intervention
Oxygen - normoxia +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02361944
NCT02361944Phase 3Completed
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Risk of Oxygen During Cardiac Surgery (ROCS) Trial

Vanderbilt University·interventional·Posted Feb 12, 2015·Updated Feb 1, 2024

In Brief

A Phase 3 clinical trial evaluating Oxygen - normoxia and Oxygen - hyperoxia for Cardiac Surgery. Completed, enrolled 213 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Surgery
CountriesUnited States
CollaboratorsNational Institute of General Medical Sciences (NIGMS)

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 12, 2015
Enrollment StartApr 5, 2016
Primary CompletionOct 8, 2020
Study CompletionJan 8, 2021
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 11.4 years ago

Interventions

Oxygen - normoxiadrug

Titration of FIO2 to maintain normal hemoglobin oxygen saturation (95-97%)

Oxygen - hyperoxiadrug

Administration of 1.0 FIO2 during ventilation and 0.8 or above during cardiopulmonary bypass