Clinical trial NCT02361944: Risk of Oxygen During Cardiac Surgery Trial
Official title: Risk of Oxygen During Cardiac Surgery (ROCS) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cardiac Surgery
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
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2015-02-12
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Intraoperative Systemic Oxidative Damage
timeFrame: separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention)
measure: Acute Kidney Injury
timeFrame: baseline to postoperative day 2
Secondary outcomes:
measure: Vascular Reactivity / Endothelial Function (as Measured by Flow Mediated Dilation)
timeFrame: ICU admission (immediately after arrival in ICU from operating room)
measure: Mitochondrial Function
timeFrame: up to 2 days following surgery
measure: Number of People With Arrhythmia
timeFrame: from surgery to hospital discharge, average of 6 days following surgery
measure: Myocardial Injury or Infarction
timeFrame: morning of postoperative day 1
measure: Number of People With Stroke
timeFrame: from surgery to hospital discharge, average of 6 days following surgery
measure: Postoperative Cognitive Dysfunction
timeFrame: up to 18 months following surgery
measure: Respiratory Failure
timeFrame: from surgery to hospital discharge, average of 6 days following surgery
measure: Chronic Kidney Disease
timeFrame: 12 months following surgery
measure: Inflammation
timeFrame: up to 2 days following surgery
measure: Hemolysis
timeFrame: separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention)
measure: Reactive Oxygen Species Production
timeFrame: 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)
measure: Acute Brain Dysfunction (Delirium)
timeFrame: from surgery to hospital discharge, average of 6 days following surgery
measure: Oxygenation and Perfusion (Lactate)
timeFrame: ICU admission (immediately after arrival in ICU from operating room)
measure: Acute Kidney Injury, According to KDIGO Criteria
timeFrame: up to 7 days following surgery
measure: Acute Kidney Injury Estimated by Urine Concentration of TIMP-2 IGFBP7
timeFrame: baseline to 2 days following surgery
measure: Acute Kidney Injury Estimated by Urine Concentration of NGAL
timeFrame: baseline to 2 days following surgery
measure: Reactive Oxygen Species Production
timeFrame: 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)
measure: Oxygenation and Perfusion (SpO2)
timeFrame: during surgery
measure: Oxygenation and Perfusion (PaO2)
timeFrame: 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)
measure: Oxygenation and Perfusion (Cerebral Oximetry)
timeFrame: continuously assessed throughout surgery and recorded each minute
measure: Oxygenation and Perfusion (SvO2)
timeFrame: 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)
measure: Oxygenation and Perfusion (Cardiac Index)
timeFrame: 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)
measure: Vascular Reactivity / Endothelial Function (Peripheral Artery Tonometry)
timeFrame: ICU admission (immediately after arrival in ICU from operating room)
measure: Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Dependent Vasodilation, EC50)
timeFrame: tissue collected during surgery when heart is exposed approximately 2 hours into intervention
measure: Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Dependent Vasodilation, Emax)
timeFrame: tissue collected during surgery when heart is exposed approximately 2 hours into intervention
measure: Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Independent Vasodilation, EC50)
timeFrame: tissue collected during surgery when heart is exposed approximately 2 hours into intervention
measure: Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Independent Vasodilation, Emax)
timeFrame: tissue collected during surgery when heart is exposed approximately 2 hours into intervention
measure: Vascular Reactivity / Endothelial Function (Tension Wire Myography, sGC Activation Vasodilation, EC50)
timeFrame: tissue collected during surgery when heart is exposed approximately 2 hours into intervention
measure: Vascular Reactivity / Endothelial Function (Tension Wire Myography, sGC Activation Vasodilation, Emax)
timeFrame: tissue collected during surgery when heart is exposed approximately 2 hours into intervention
measure: Vascular Reactivity / Endothelial Function (PAI-1)
timeFrame: 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)
measure: Vascular Reactivity / Endothelial Function (E-selectin)
timeFrame: 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)
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Frederic T. Billings, IV, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lopez 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.