Cardiac SurgeryPhase 2/3ROCSNCT02361944
Risk of Oxygen During Cardiac Surgery Trial
A Phase 2/3 study testing Oxygen - normoxia and Oxygen - hyperoxia in people with Cardiac Surgery, run by Vanderbilt University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Oxygen - normoxia and Oxygen - hyperoxia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2016to 8 Jan 2021
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Open-heart cardiac surgery, defined as surgery on the heart or aorta that requires sternotomy or thoracotomy.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: 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.
- Conditions
- Cardiac Surgery
- Being tested
- Oxygen - normoxia, Oxygen - hyperoxia
- Keywords
- 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
- Medical subject headings
- Hyperoxia, Renal Insufficiency, Delirium, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen - normoxiaDrug
Also called oxygen
Titration of FIO2 to maintain normal hemoglobin oxygen saturation (95-97%)
Oxygen - hyperoxiaDrug
Also called oxygen
Administration of 1.0 FIO2 during ventilation and 0.8 or above during cardiopulmonary bypass
| Study group | Role | What they receive |
|---|---|---|
| Normoxia | Experimental | Oxygen administration to maintain a hemoglobin oxygen saturation of 95-97% or arterial PaO2 80-110 mmHg during surgery. Receives: Drug: Oxygen - normoxia |
| Hyperoxia | Active comparator | Fraction of inspired oxygen 1.0 during mechanical ventilation and 0.8 during cardiopulmonary bypass during surgery. Receives: Drug: Oxygen - hyperoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Systemic Oxidative Damage
quantified by measuring F2-isoprostanes isofurans following separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting
Measured: 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
Measured: baseline to postoperative day 2
Secondary outcomes (31)
Vascular Reactivity / Endothelial Function (as Measured by Flow Mediated Dilation)
brachial artery flow mediated dilation assessed when patient arrives in ICU after surgery. brachial artery flow mediated dilation is represented as the percent change in brachial artery diameter following 5 minutes of artery occlusion. The entire assessment takes place at ICU admission.
Measured: ICU admission (immediately after arrival in ICU from operating room)
Mitochondrial Function
mitochondrial function in atrial myocardium estimated by quantifying adenylate kinase at the end of surgery and oxygen intervention
Measured: up to 2 days following surgery
Number of People With Arrhythmia
defined as any atrial fibrillation following surgery until hospital discharge assessed using continuous telemetry, rhythm strips, and electrocardiograms
Measured: from surgery to hospital discharge, average of 6 days following surgery
Myocardial Injury or Infarction
plasma concentration of creatine kinase, myocardial band
Measured: morning of postoperative day 1
Number of People With Stroke
Defined as new deficit on neurologic exam and confirmed with radiologic evidence occurring at any point prior to hospital discharge
Measured: from surgery to hospital discharge, average of 6 days following surgery
Postoperative Cognitive Dysfunction
Median change scores at the Short Blessed Scale (SBT) administered one-year following surgery. The SBT is a validated rating scale, administered by the clinician, measuring the cognitive performance. Sum Total (range 0-28) with 0 indicating no cognitive impairment and 28 indicating severe cognitive impairment.
Measured: up to 18 months following surgery
Respiratory Failure
reintubation
Measured: from surgery to hospital discharge, average of 6 days following surgery
Chronic Kidney Disease
eGFR one year following surgery
Measured: 12 months following surgery
Inflammation
Estimated by quantifying plasma concentration of plasminogen activator inhibitor-1 (PAI-1)
Measured: up to 2 days following surgery
Hemolysis
plasma free hemoglobin
Measured: separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention)
Reactive Oxygen Species Production
TMH electron spin probe
Measured: end of surgery, defined as immediately after separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention)
Acute Brain Dysfunction (Delirium)
The number of participants with acute brain dysfunction as assessed by the Confusion Assessment Method for the ICU (CAM-ICU) twice daily while patients are in the ICU or for first 3 postoperative days.
Measured: from surgery to hospital discharge, average of 6 days following surgery
Oxygenation and Perfusion (Lactate)
arterial lactate measured from arterial blood collected at ICU admission (immediately after arrival in ICU from operating room)
Measured: ICU admission (immediately after arrival in ICU from operating room)
Acute Kidney Injury, According to KDIGO Criteria
KDIGO acute kidney injury is defined as an increase in SCr ≥ 0.3 mg/dL (≥ 26.5 lmol/L) within 48 hours of surgery or 1.5 to 1.9 times baseline within 7 days of surgery
Measured: up to 7 days following surgery
Acute Kidney Injury Estimated by Urine Concentration of TIMP-2 IGFBP7
Urinary concentration of [TIMP2]*[IGFBP7] 6 hours after ICU admission
Measured: baseline to 2 days following surgery
Acute Kidney Injury Estimated by Urine Concentration of NGAL
Urinary concentration of neutrophil gelatinase-associated lipocalin (NGAL) 6 hours after ICU admission.
Measured: baseline to 2 days following surgery
Reactive Oxygen Species Production
CAT1H electron spin probe
Measured: end of surgery, defined as immediately after separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention)
Oxygenation and Perfusion (SpO2)
hemoglobin O2 saturation summarized using SpO2 data continuously measured and recorded every minute during surgery. We calculated the median SpO2 throughout surgery using all the minute to minute values. For example, if a participant had a 5 hour (300 minutes) long surgery, the participant would have 300 SpO2 measurements. We calculated and report the median of those measurements.
Measured: during surgery
Oxygenation and Perfusion (PaO2)
partial pressure of oxygen in arterial blood measured from blood sampled at end of surgery, defined as following separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention)
Measured: end of surgery, defined as separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention)
Oxygenation and Perfusion (Cerebral Oximetry)
brain hemoglobin oxygenation using near-infrared spectroscopy (NIRS). The median percent changes from baseline (baseline measured at beginning of surgery when probes placed on forehead, prior to intervention) throughout surgery was calculated using cerebral oximetry measurements collected every minute throughout surgery. We calculated the difference between baseline and each measurement throughout surgery. For example, if a participant had a 5 hour (300 minutes) long surgery, the participant would have 300 cerebral oximetry measurements. We calculated and report the median of those measurements.
Measured: continuously assessed throughout surgery and recorded each minute
Oxygenation and Perfusion (SvO2)
mixed venous O2 saturation, measured from blood sampled from pulmonary artery sampled at end of surgery, defined as following separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention)
Measured: end of surgery, defined as following separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention)
Oxygenation and Perfusion (Cardiac Index)
cardiac output (normalized to body surface area, i.e., cardiac index)
Measured: end of surgery, defined as immediately after separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention)
Vascular Reactivity / Endothelial Function (Peripheral Artery Tonometry)
reactive hyperemia index measured at ICU admission (immediately after arrival in ICU from operating room). The reactive hyperemia index is a number generated by an endopat machine performing peripheral artery tonometry. The index ranges from approximately 1-3, where higher values indicate better vascular reactivity and endothelial function.
Measured: ICU admission (immediately after arrival in ICU from operating room)
Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Dependent Vasodilation, EC50)
Effective concentration for 50% dilation acetylcholine dose response, tension wire myography from arterioles dissected from epicardial fat
Measured: tissue collected during surgery when heart is exposed approximately 2 hours into intervention
Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Dependent Vasodilation, Emax)
Maximum percentage of arteriole dilation after increasing doses of acetylcholine measured using tension wire myography of arterioles dissected from epicardial fat. The fat sample was collected during surgery when heart is exposed approximately 2 hours into intervention.
Measured: tissue collected during surgery when heart is exposed approximately 2 hours into intervention
Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Independent Vasodilation, EC50)
Effective concentration for 50% dilation sodium nitroprusside dose response, tension wire myography from arterioles dissected from epicardial fat
Measured: tissue collected during surgery when heart is exposed approximately 2 hours into intervention
Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Independent Vasodilation, Emax)
Maximum percentage of arteriole dilation after increasing doses of sodium nitroprusside measured using tension wire myography of arterioles dissected from epicardial fat. The fat sample was collected during surgery when heart is exposed approximately 2 hours into intervention.
Measured: tissue collected during surgery when heart is exposed approximately 2 hours into intervention
Vascular Reactivity / Endothelial Function (Tension Wire Myography, sGC Activation Vasodilation, EC50)
Effective concentration for 50% dilation cinaciguat dose response, tension wire myography from arterioles dissected from epicardial fat
Measured: tissue collected during surgery when heart is exposed approximately 2 hours into intervention
Vascular Reactivity / Endothelial Function (Tension Wire Myography, sGC Activation Vasodilation, Emax)
Maximum percentage of arteriole dilation after increasing doses of cinaciguat measured using tension wire myography of arterioles dissected from epicardial fat. The fat sample was collected during surgery when heart is exposed approximately 2 hours into intervention.
Measured: tissue collected during surgery when heart is exposed approximately 2 hours into intervention
Vascular Reactivity / Endothelial Function (PAI-1)
Plasminogen activator inhibitor 1
Measured: end of surgery, defined as immediately after separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention)
Vascular Reactivity / Endothelial Function (E-selectin)
E-selectin
Measured: end of surgery, defined as immediately after separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study start5 Apr 2016
- Primary completion8 Oct 2020
- Study completion8 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Frederic T Billings IV, Vanderbilt University
- Investigators
- Frederic T. Billings, IV, MD, MSc, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361944
- Sponsor's protocol ID
- 131128
- Other IDs
- R01GM112871
- Acronym
- ROCS
- Status last verified
- Jan 2024
- First submitted
- 30 Jan 2015
- Last updated
- 1 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 40673571Lopez 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.
PubMed 39110454Lopez 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.
PubMed 28651648
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Oxygen During Cardiac Surgery (ROCS) Trial
- ClinicalTrials.gov ID
- NCT02361944
- Acronym / sponsor ID
- ROCS / 131128
- Conditions
- Cardiac Surgery
- Keywords
- oxygen, hyperoxia, reactive oxygen species, oxidative stress, oxidative damage, endothelial function, vascular reactivity, mitochondrial function
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 5 Apr 2016 (actual)
- Primary completion
- 8 Oct 2020 (actual)
- Study completion
- 8 Jan 2021 (actual)
- First posted
- 12 Feb 2015 (estimated)
- Results
- Posted 14 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normoxia | Experimental | Drug: Oxygen - normoxiaOxygen administration to maintain a hemoglobin oxygen saturation of 95-97% or arterial PaO2 80-110 mmHg during surgery. |
| Hyperoxia | Active comparator | Drug: Oxygen - hyperoxiaFraction of inspired oxygen 1.0 during mechanical ventilation and 0.8 during cardiopulmonary bypass during surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Open-heart cardiac surgery, defined as surgery on the heart or aorta that requires sternotomy or thoracotomy.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen - normoxiaAlso: oxygenTitration of FIO2 to maintain normal hemoglobin oxygen saturation (95-97%) | Drug | Normoxia |
| Oxygen - hyperoxiaAlso: oxygenAdministration of 1.0 FIO2 during ventilation and 0.8 or above during cardiopulmonary bypass | Drug | Hyperoxia |
Primary outcome
Intraoperative Systemic Oxidative Damage
Time frame: separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention)
quantified by measuring F2-isoprostanes isofurans following separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting
Acute Kidney Injury
Time frame: baseline to postoperative day 2
quantified by change in serum creatinine concentration
31 secondary outcomes
Vascular Reactivity / Endothelial Function (as Measured by Flow Mediated Dilation)
Time frame: ICU admission (immediately after arrival in ICU from operating room)
Mitochondrial Function
Time frame: up to 2 days following surgery
Number of People With Arrhythmia
Time frame: from surgery to hospital discharge, average of 6 days following surgery
Myocardial Injury or Infarction
Time frame: morning of postoperative day 1
Number of People With Stroke
Time frame: from surgery to hospital discharge, average of 6 days following surgery
Postoperative Cognitive Dysfunction
Time frame: up to 18 months following surgery
Respiratory Failure
Time frame: from surgery to hospital discharge, average of 6 days following surgery
Chronic Kidney Disease
Time frame: 12 months following surgery
Inflammation
Time frame: up to 2 days following surgery
Hemolysis
Time frame: separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention)
Reactive Oxygen Species Production
Time frame: end of surgery, defined as immediately after separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention)
Acute Brain Dysfunction (Delirium)
Time frame: from surgery to hospital discharge, average of 6 days following surgery
Oxygenation and Perfusion (Lactate)
Time frame: ICU admission (immediately after arrival in ICU from operating room)
Acute Kidney Injury, According to KDIGO Criteria
Time frame: up to 7 days following surgery
Acute Kidney Injury Estimated by Urine Concentration of TIMP-2 IGFBP7
Time frame: baseline to 2 days following surgery
Acute Kidney Injury Estimated by Urine Concentration of NGAL
Time frame: baseline to 2 days following surgery
Reactive Oxygen Species Production
Time frame: end of surgery, defined as immediately after separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention)
Oxygenation and Perfusion (SpO2)
Time frame: during surgery
Oxygenation and Perfusion (PaO2)
Time frame: end of surgery, defined as separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention)
Oxygenation and Perfusion (Cerebral Oximetry)
Time frame: continuously assessed throughout surgery and recorded each minute
Oxygenation and Perfusion (SvO2)
Time frame: end of surgery, defined as following separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention)
Oxygenation and Perfusion (Cardiac Index)
Time frame: end of surgery, defined as immediately after separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention)
Vascular Reactivity / Endothelial Function (Peripheral Artery Tonometry)
Time frame: ICU admission (immediately after arrival in ICU from operating room)
Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Dependent Vasodilation, EC50)
Time frame: tissue collected during surgery when heart is exposed approximately 2 hours into intervention
Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Dependent Vasodilation, Emax)
Time frame: tissue collected during surgery when heart is exposed approximately 2 hours into intervention
Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Independent Vasodilation, EC50)
Time frame: tissue collected during surgery when heart is exposed approximately 2 hours into intervention
Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Independent Vasodilation, Emax)
Time frame: tissue collected during surgery when heart is exposed approximately 2 hours into intervention
Vascular Reactivity / Endothelial Function (Tension Wire Myography, sGC Activation Vasodilation, EC50)
Time frame: tissue collected during surgery when heart is exposed approximately 2 hours into intervention
Vascular Reactivity / Endothelial Function (Tension Wire Myography, sGC Activation Vasodilation, Emax)
Time frame: tissue collected during surgery when heart is exposed approximately 2 hours into intervention
Vascular Reactivity / Endothelial Function (PAI-1)
Time frame: end of surgery, defined as immediately after separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention)
Vascular Reactivity / Endothelial Function (E-selectin)
Time frame: end of surgery, defined as immediately after separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40673571Lopez 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.
- Derived from this study: PubMed 39110454Lopez 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.
- Derived from this study: PubMed 28651648Lopez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic T. Billings, IV, MD, MSc principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oxygen - normoxia and Oxygen - hyperoxia in people with Cardiac Surgery, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Systemic Oxidative Damage (time frame: separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02361944, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.