Risk of Oxygen During Cardiac Surgery Trial
ROCS
2 other identifiers
interventional
213
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2016
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2015
CompletedFirst Posted
Study publicly available on registry
February 12, 2015
CompletedStudy Start
First participant enrolled
April 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 8, 2021
CompletedResults Posted
Study results publicly available
August 14, 2023
CompletedFebruary 1, 2024
January 1, 2024
4.5 years
January 30, 2015
July 19, 2023
January 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Intraoperative Systemic Oxidative Damage
quantified by measuring F2-isoprostanes isofurans following separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting
separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention)
Acute Kidney Injury
quantified by change in serum creatinine concentration
baseline to postoperative day 2
Secondary Outcomes (31)
Vascular Reactivity / Endothelial Function (as Measured by Flow Mediated Dilation)
ICU admission (immediately after arrival in ICU from operating room)
Mitochondrial Function
up to 2 days following surgery
Number of People With Arrhythmia
from surgery to hospital discharge, average of 6 days following surgery
Myocardial Injury or Infarction
morning of postoperative day 1
Number of People With Stroke
from surgery to hospital discharge, average of 6 days following surgery
- +26 more secondary outcomes
Study Arms (2)
Normoxia
EXPERIMENTALOxygen administration to maintain a hemoglobin oxygen saturation of 95-97% or arterial PaO2 80-110 mmHg during surgery.
Hyperoxia
ACTIVE COMPARATORFraction of inspired oxygen 1.0 during mechanical ventilation and 0.8 during cardiopulmonary bypass during surgery.
Interventions
Titration of FIO2 to maintain normal hemoglobin oxygen saturation (95-97%)
Administration of 1.0 FIO2 during ventilation and 0.8 or above during cardiopulmonary bypass
Eligibility Criteria
You may qualify if:
- Open-heart cardiac surgery, defined as surgery on the heart or aorta that requires sternotomy or thoracotomy.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Related Publications (3)
Lopez MG, Pandey AK, Hennessy C, Hughes CG, Absi TS, Shah AS, Shotwell MS, Harrison DG, Billings FT 4th; ROCS Trial Investigators. Effects of Oxygen on Perioperative Vascular Function: A Randomized Clinical Trial. J Am Heart Assoc. 2025 Aug 5;14(15):e041778. doi: 10.1161/JAHA.125.041778. Epub 2025 Jul 17.
PMID: 40673571DERIVEDLopez MG, Shotwell MS, Hennessy C, Pretorius M, McIlroy DR, Kimlinger MJ, Mace EH, Absi T, Shah AS, Brown NJ, Billings FT 4th; ROCS trial investigators. Intraoperative Oxygen Treatment, Oxidative Stress, and Organ Injury Following Cardiac Surgery: A Randomized Clinical Trial. JAMA Surg. 2024 Oct 1;159(10):1106-1116. doi: 10.1001/jamasurg.2024.2906.
PMID: 39110454DERIVEDLopez MG, Pretorius M, Shotwell MS, Deegan R, Eagle SS, Bennett JM, Sileshi B, Liang Y, Gelfand BJ, Kingeter AJ, Siegrist KK, Lombard FW, Richburg TM, Fornero DA, Shaw AD, Hernandez A, Billings FT 4th. The Risk of Oxygen during Cardiac Surgery (ROCS) trial: study protocol for a randomized clinical trial. Trials. 2017 Jun 26;18(1):295. doi: 10.1186/s13063-017-2021-5.
PMID: 28651648DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Frederic T. BIllings IV
- Organization
- Vanderbilt University
Study Officials
- PRINCIPAL INVESTIGATOR
Frederic T. Billings, IV, MD, MSc
Vanderbilt University Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Anesthesiology
Study Record Dates
First Submitted
January 30, 2015
First Posted
February 12, 2015
Study Start
April 5, 2016
Primary Completion
October 8, 2020
Study Completion
January 8, 2021
Last Updated
February 1, 2024
Results First Posted
August 14, 2023
Record last verified: 2024-01