Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Normoxia
Oxygen administration to maintain a hemoglobin oxygen saturation of 95-97% or arterial PaO2 80-110 mmHg during surgery.
  • Drug: Oxygen
Active Comparator
Hyperoxia
Fraction of inspired oxygen 1.0 during mechanical ventilation and 0.8 during cardiopulmonary bypass during surgery.
  • Drug: Oxygen

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37212
Contact:
Frederic T. Billings, IV, MD, MSc
615-343-6479
frederic.t.billings@vanderbilt.edu

More Details

NCT ID
NCT02361944
Status
Recruiting
Sponsor
Vanderbilt University

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.