Risk of Oxygen During Cardiac Surgery Trial



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:10/10/2018
Start Date:April 2016
End Date:December 2020

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Trial Summary
Trial Overview
Inclusion Criteria

Risk of Oxygen During Cardiac Surgery (ROCS) Trial

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.


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
We found this trial at
1
site
Vanderbilt University Medical Center
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-343-6479
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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