Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest

Study Overview
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Brief Summary
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To study the effects of ubiquinol as a metabolic resuscitator in post-cardiac arrest.

Detailed Description
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Cardiac arrest (CA) occurs in more than 400,000 patients in the United States each year with an estimated mortality of greater than 90%. The majority of patients who are resuscitated from CA will succumb to the neurologic morbidity associated with the post-CA syndrome and ischemic-reperfusion injury. Currently, there are no pharmacologic agents known to offer survival benefit or to prevent devastating neurologic injury in post-CA patients. A potential therapeutic target following ischemia-reperfusion injury is mitochondrial function in the injured cell and/or reduction of oxygen free radicals. Coenzyme Q10 (CoQ10) is an essential mitochondrial co-factor and free radical scavenger that has been proposed as a neuroprotective agent in various neurodegenerative disorders as well as a cardioprotective agent. CoQ10 have furthermore shown exciting preliminary results as a potential therapy in post-CA. In order to test the effects of ubiquinol as a metabolic resuscitator in post-CA patients and to provide additional preliminary data for a large-scale clinical trial, the investigators are conducting a randomized, double-blind, place-controlled trial of ubiquinol in post-CA patients.

Official Title
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Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Drug: Ubiquinol
* Dietary Supplement: Ensure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (≥ 18 years) Cardiac arrest defined by cessation of pulse requiring chest compressions Not following commands after ROSC Admission to the ICU Naso/orogastric tube Ability to receive enteral medication Exclusion Criteria: Protected populations (pregnant women, prisoners, the intellectual disabled) Current CoQ10 supplementation Anticipated death within 24 hours > 12 hours from ROSC to estimated randomization Jejunostomy tube (J-tube)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Patients in the control group will receive a liquid placebo, which is 50 mL of Ensure (a dietary supplement). This will be given every 12 hours for 7 days, until neurologic recovery, or until hospital discharge. | Dietary Supplement: Ensure<br>* 50 mL Ensure<br>|
| Experimental: Ubiquinol<br>Patients in the experimental group will receive 300 mg of Ubiquinol in a liquid mixture. The liquid Ubiquinol will be mixed with 50 mL of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days, until neurologic recovery, or until hospital discharge. | Drug: Ubiquinol<br>* 300 mg Ubiquinol (3 mL liquid Ubiquinol).<br>* Other names: CoQ10;Dietary Supplement: Ensure<br>* 50 mL Ensure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coenzyme Q10 Plasma Levels | Total (oxidized and reduced form) coenzyme Q10 | Up to 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased Neurological Injury | Neuron Specific Enolase levels | Up to 72 hours | 
| Cellular Oxygen Consumption | Cellular (peripheral blood mononuclear cells) oxygen consumption measured with the XFe24 Extracellular Flux Analyzer | At 24 hours | 
| Global Oxygen Consumption | VO2 measured using a Compact Anesthesia monitor | Up to 48 hours | 
| Mortality | In-hospital mortality | At hospital discharge, an average of 14 days | 
| Number of Participants With Favorable Neurological Outcome | Favorable Neurological Outcome as measured by the Cerebral Performance Category (CPC 1-2) score. A CPC score of 1 (mild or no neurological deficit) or 2 (moderate disability) was defined as a favorable neurological outcome. A CPC score of 3 (severe disability), 4 (vegetative state), or 5 (death) was defined as an unfavourable neurological outcome. | At hospital discharge, an average of 14 days |