An interventional study of Cerebral oximetry-guided treatment in Post-Cardiac Arrest Syndrome, Post Cardiac Arrest Brain Injury and Hypoxic-Ischemic Brain Injury, sponsored by University of Calgary. Recruiting at 1 site in Canada. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by University of Calgary · Not applicable, Interventional, and Treatment
Resuscitation from a cardiac arrest is a common reason for admission to an intensive care unit (ICU).
Because the brain is highly vulnerable to oxygen deprivation, severe brain damage often occurs during a cardiac arrest. Even when the heart has been restarted, there may continue to be reduced blood flow and oxygen delivery to the brain for many hours. ICU professionals generally do not use any tools to detect low oxygen delivery to the brain.
Most patients admitted to the ICU are initially in a coma and many will never awaken. Even if they regain consciousness, there may be long-term cognitive and functional disabilities. There are currently no specific treatments available to ICU professionals that are proven to limit brain damage and improve outcomes.
Cerebral oximetry is a non-invasive, painless, safe, and easy-to-use tool that detects reduced oxygen delivery to the brain using a sensor over the forehead. Previous research shows that reduced brain oxygen levels [(regional oxygen saturation (RSO2)] are predictive of a lower chance of awakening and having a good neurological recovery.
This study will assess treatment guided by cerebral oximetry during the initial 48 hours following cardiac arrest. Patients that are in a coma after their circulation has been restarted will be randomly allocated to either usual care based on international guidelines or a protocol aimed at maintaining RSO2 above 60% on both sides of the brain.
Cerebral oximetry will be recorded in all patients, but doctors will only be aware of it in one group. If RSO2 drops below 60% for more than 5 minutes, doctors will try to increase it. Actions taken to increase RSO2 may include raising the blood pressure by giving more intravenous fluid or using life-support drugs ("vasoconstrictors" like norepinephrine), stimulating the heart to pump more strongly with medications ("inotropes" like dobutamine, milrinone, or epinephrine), adjusting ventilator settings (to increase the amount of oxygen dissolved in blood or raise carbon dioxide levels, which increases blood flow to the brain), lowering the head of the bed (to increase blood flow to the brain), or giving a blood transfusion (only if the patient has anemia). When RSO2 has been corrected to at least 60% for more than 2 hours, doctors may reverse previous interventions. If they are unable to achieve the goal of 60%, they may lower the target. Efforts to maintain RSO2 in the target range will continue for 48 hours.
Investigators will assess how well the protocol works and whether it helps avoid critically low brain oxygen levels. Investigators will also measure various "biomarkers" in the blood that are released when the brain is damaged to see if they are lower when cerebral oximetry is used to guide treatment.
31 studies on the registry are indexed under Post-Cardiac Arrest Syndrome; 11 are open to participants now.
This study's planned enrollment of 44 is below the median of 158 across 17 interventional studies indexed under Post-Cardiac Arrest Syndrome.
Browse Post-Cardiac Arrest Syndrome studies →University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Clinicians are unmasked to regional oxygen saturation levels and attempt to maintain it at 60% or above.
Other: Cerebral oximetry-guided treatment
Clinicians are unaware of regional oxygen saturation levels and manage patients in accordance with international (ILCOR) guidelines.
Initial goals are consistent with ILCOR guidelines. When RSO2 \< 60%, treatment options include: 1. Raise MAP by 5 mmHg (recommended if MAPopt \> MAPactual; maximum 85-90 mmHg). 2. Raise PCO2 by 5 mmHg (maximum 50-55 mmHg); 3. Increase PO2 to 100-150 mmHg (raise FIO2 or PEEP). 4. Increase cardiac output using fluid (if intravascular volume depletion) or inotrope (if impaired systolic function). 5. Lower head of bed (HOB) 15 degrees (consider reducing nutrition and suctioning stomach) 6. If the HB concentration \< 9-10 g/dL, transfuse one unit RBCs. MAPopt (MAP range where autoregulation best preserved) determined once daily. The order of interventions are at the discretion of the most responsible physician. Treatments should occur within 15 minutes and be separated by at least 15 minutes. If treatments ineffective or considered unsafe, target can be dropped by 5% (minimum 50%). If RSO2 stable for 2-4 hours, previous interventions can be reversed.
Area under the curve (RSO2 < 60%)
Sum of right and left forehead area under the curve (AUC), where AUC = (average reduction in RSO2 below 60% per minute) x (2880 minutes)
Time frame: 48 hours (2880 minutes)
Area under the curve (RSO2 < 60%) in patients where initial RSO2 < 60%
Sum of right and left forehead area under the curve (AUC), where AUC = (average reduction in RSO2 below 60% per minute) x (2880 minutes) in patients where initial RSO2 \< 60%
Time frame: 48 hours (2880 minutes)
Proportion of monitoring time with RSO2 < 60%
(Number of minutes with RSO2 \< 60%) / (Number of minutes monitored)
Time frame: Maximum of 48 hours (2880 minutes)
Proportion of monitoring time with RSO2 < 60% in patients where initial RSO2 < 60%
(Number of minutes with RSO2 \< 60%) / (Number of minutes monitored)
Time frame: Maximum of 48 hours (2880 minutes)
Change in RSO2 over time in patients where baseline level < 60%
Assessed using generalized estimating equation linear models with autoregressive correlation structure
Time frame: Initial 6 hours
Dichotomized Cerebral Performance Category (CPC)
CPC 1-2 = favourable outcome, CPC 3-5 = poor outcome
Time frame: 3 months
28-day mortality
Proportion dead at 28 days post-arrest
Time frame: 28 days
Difference between baseline and day 3 biomarker levels
Baseline level measured as soon as possible following ROSC. Day 3 level measured on third morning in ICU at about 8 a.m.. Biomarkers measured will include neuron specific enolase, neurofilament light, and tau.
Time frame: 3 days
Optic nerve sheath diameter
Average of bilateral measurements, two planes per eye (4 total measurements)
Time frame: Days 1, 2, and 3 post-arrest
Serious Adverse Events (SAE)
Neurologic: seizures, herniation syndromes, progression to death by neurological criteria Cardiovascular: arrhythmias, development of cardiogenic shock, recurrent cardiac arrest Respiratory: ARDS, pulmonary edema Gastrointestinal: mesenteric ischemia Acute kidney injury: based on KDIGO definition
Time frame: Initial 7 days post-arrest
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Post-Cardiac Arrest Syndrome →