Cerebral Oximetry in Management of Post Cardiac Arrest

NCT07829887 | Recruiting

• 1 other identifier: REB19-0216_REN8
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

  48 hours (2880 minutes)

Secondary Outcomes (9)

• Area under the curve (RSO2 < 60%) in patients where initial RSO2 < 60%

  48 hours (2880 minutes)

• Proportion of monitoring time with RSO2 < 60%

  Maximum of 48 hours (2880 minutes)

• Proportion of monitoring time with RSO2 < 60% in patients where initial RSO2 < 60%

  Maximum of 48 hours (2880 minutes)

• Change in RSO2 over time in patients where baseline level < 60%

  Initial 6 hours

• Dichotomized Cerebral Performance Category (CPC)

  3 months

Study Arms (2)

Cerebral oximetry-guided treatment

EXPERIMENTAL

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

Other: Cerebral oximetry-guided treatment

Standard care

NO INTERVENTION

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

Interventions

Cerebral oximetry-guided treatment OTHER

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.

Cerebral oximetry-guided treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Intensive Care Foundation: collaborator

Study Sites (1)

Foothills Medical Center

Calgary, Alberta, T3Z 3L7, Canada

RECRUITING

Related Publications (1)

• Phillips A, Bencsik C, Bains I, McKenzie E, Wong A, Couillard P, Kromm JA, Kramer AH. Relationship Between Cerebral Oximetry and Outcomes in Post-Cardiac Arrest Patients: A Systematic Review and Meta-Analysis. Crit Care Explor. 2026 Jul 2;8(7):e1427. doi: 10.1097/CCE.0000000000001427. eCollection 2026 Jul 1.

  PMID: 42390940 BACKGROUND

MeSH Terms

Conditions

Post-Cardiac Arrest Syndrome; Hypoxia-Ischemia, Brain; Heart Arrest; Hypoxia, Brain; Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Heart Diseases; Cardiovascular Diseases; Reperfusion Injury; Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Ischemia; Cerebrovascular Disorders; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms

Central Study Contacts

Andreas H Kramer, MD MSc FRCPC

CONTACT

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

Ish Bains, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There is no masking of which group the patient is in. However, for patients in the control arm, ICU professionals are masked to the cerebral oximetry readings.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: September 21, 2026
• Study Start: October 10, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-08

Locations

CA (1)