ClinicalTrials.gov
ClinicalTrials.gov Menu

Risk of Oxygen During Cardiac Surgery Trial (ROCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02361944
Recruitment Status : Recruiting
First Posted : February 12, 2015
Last Update Posted : October 20, 2017
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Frederic T Billings IV, Vanderbilt University

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiac Surgery Drug: Oxygen Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Risk of Oxygen During Cardiac Surgery (ROCS) Trial
Study Start Date : April 2016
Estimated Primary Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. oxidative damage is the primary outcome of aim 2 (mechanism of organ injury) [ Time Frame: up to 2 days following surgery ]
    quantified by measuring F2-isoprostanes/isofurans

  2. acute kidney injury is the primary outcome of aim 1 (organ injury) [ Time Frame: up to 1 week following surgery ]
    quantified by change in serum creatinine concentration (primary endpoint), KDIGO criteria, and urine concentrations of IGFBP7, TIMP-2, and NGAL.


Secondary Outcome Measures :
  1. vascular reactivity / endothelial function [ Time Frame: up to 2 days following surgery ]
    measured by brachial artery flow mediated dilation, peripheral artery tonometry, tension wire myogrpahy from arterioles dissected from epicardial fat, and biomarkers including PAI-1 and e-selectin

  2. mitochondrial function [ Time Frame: up to 2 days following surgery ]
    in peripheral blood mononuclear cells and atrial myocardium

  3. arrythmia [ Time Frame: duration of hospitalization, average of 6 days following surgery ]
    atrial fibriallation

  4. myocardial injury or infarction [ Time Frame: duration of hospitalization, average of 6 days following surgery ]
  5. stroke [ Time Frame: duration of hospitalization, average of 6 days following surgery ]
  6. postoperative cognitive dysfunction, pain, and depression [ Time Frame: up to 18 months following surgery ]
  7. mortality [ Time Frame: up to 18 months following surgery ]
  8. respiratory failure [ Time Frame: duration of hospitalization, average of 6 days following surgery ]
    PF ratios, reintubation

  9. chronic kidney disease [ Time Frame: up to 18 months following surgery ]
    MAKE criteria (eGFR, dialysis, death)

  10. inflammation [ Time Frame: up to 2 days following surgery ]
  11. hemolysis [ Time Frame: up to 2 days following surgery ]
    plasma free hemoglobin

  12. reactive oxygen species production [ Time Frame: up to 1 day following surgery ]
    TMH and CAT1H electron spin probes, and dihydroethidium.

  13. acute brain dysfunction (delirium) [ Time Frame: up to 1 week following surgery ]
    assessed by CAM-ICU twice daily while patients are in the ICU or for first 3 postoperative days

  14. oxygenation and perfusion [ Time Frame: up to 1 day following surgery ]
    hemoglobin O2 saturation, PaO2, brain and muscle oxygenation using NIRS, mixed venous O2 saturation, cardiac output, arterial lactate



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361944


Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Frederic T. Billings, IV, MD, MSc    615-343-6479    frederic.t.billings@vanderbilt.edu   
Sponsors and Collaborators
Vanderbilt University
National Institute of General Medical Sciences (NIGMS)
Investigators
Principal Investigator: Frederic T. Billings, IV, MD, MSc Vanderbilt University Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Frederic T Billings IV, Assistant Professor of Anesthesiology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02361944     History of Changes
Other Study ID Numbers: 131128
R01GM112871 ( U.S. NIH Grant/Contract )
First Posted: February 12, 2015    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017

Keywords provided by Frederic T Billings IV, Vanderbilt University:
oxygen
hyperoxia
reactive oxygen species
oxidative stress
oxidative damage
endothelial function
vascular reactivity
mitochondrial function
surgery
anesthesia
kidney injury
renal failure
delirium
myocardial injury
arrythmia