Cerebral Oximetry in Management of Post Cardiac Arrest
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Calgary
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >= 18 years
Cardiac arrest (in- or out-of-hospital) lasting >= 5 minutes
Glasgow Coma Scale score <= 8 and motor score <= 5
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cerebral oximetry-guided treatment
Other interventionInitial 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.
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Cerebral oximetry-guided treatmentExperimental treatment 1 intervention
Group B: Standard careNo intervention 0 interventions
Trial outcomes
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)
Time frame
48 hours (2880 minutes)Secondary outcomes
1
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)2
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)3
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)4
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 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Calgary
Lead sponsor
Canadian Intensive Care Foundation
Collaborator
Source ClinicalTrials.gov