MedTrace Logo

Risk of Oxygen During Cardiac Surgery Trial

NCT02361944 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2024-02-01

Study results available
· View outcomes & findings →

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

  • Cardiac Surgery

Interventions

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

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Frederic T. Billings, IV, MD, MSc · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-05
Primary Completion
2020-10-08
Completion
2021-01-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02361944 on ClinicalTrials.gov