Recruiting

Cerebral Oximetry

Sponsor:

University of Calgary

Code:

NCT07829887

Conditions

Post-Cardiac Arrest Syndrome

Post Cardiac Arrest Brain Injury

Hypoxic-Ischemic Brain Injury

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Cerebral oximetry-guided treatment

Study Details

Brief summary:

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.

Conditions

Post-Cardiac Arrest Syndrome

Post Cardiac Arrest Brain Injury

Hypoxic-Ischemic Brain Injury

Study ID

NCT07829887

Start date

Oct 10, 2025

Status verified date

Aug, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age >= 18 years
  • Cardiac arrest (in- or out-of-hospital) lasting >= 5 minutes
  • Glasgow Coma Scale score <= 8 and motor score <= 5

Exclusion Criteria:

  • Cardiac arrest cause was any form of brain injury
  • Cannot be enrolled within 6 hours
  • Unsupportable physiology
  • CT scan (not mandated) showing diffuse loss of grey-white differentiation

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cerebral oximetry-guided treatment

Clinicians are unmasked to regional oxygen saturation levels and attempt to maintain it at 60% or above.

no intervention: Standard care

Clinicians are unaware of regional oxygen saturation levels and manage patients in accordance with international (ILCOR) guidelines.

Interventions

Cerebral oximetry-guided treatment

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.

Primary outcome measure

  • Area under the curve (RSO2 < 60%) [ Time Frame: 48 hours (2880 minutes) ]

Central Contacts and Locations

Central contacts

Andreas H Kramer, MD MSc FRCPC

403-944-4749andreas.kramer@albertahealthservices.ca

Ish Bains, PhD

403-944-0740ish.bains@albertahealthservices.ca

Locations

Foothills Medical Center

Recruiting

Calgary, Alberta, Canada, T3Z 3L7

Contacts

Andreas Kramer, MD MSc FRCPC

4034666327andreas.kramer@albertahealthservices.ca

Ish Bains, PhD

403-944-0740ish.bains@albertahealthservices.ca

Principal Investigator:

Andreas Kramer, MD MSc FRCPC

More Information

Sponsor

University of Calgary

Last update posted

Sep 21, 2026

Last verified

Aug, 2026

Keywords

  • Heart Arrest
  • Hypoxia, brain
  • Out-of-Hospital Cardiac Arrest
  • Post-Cardiac Arrest Syndrome
  • Spectroscopy, Near-Infrared

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by University of Calgary on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.