Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest

Beth Israel Deaconess Medical Center48 enrolled

Overview

To study the effects of ubiquinol as a "metabolic resuscitator" in post-cardiac arrest.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Cardiac Arrest

Interventions

UbiquinolDRUG

300 mg Ubiquinol (3 mL liquid Ubiquinol).

EnsureDIETARY_SUPPLEMENT

50 mL Ensure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Coenzyme Q10 Plasma Levels

Total (oxidized and reduced form) coenzyme Q10

Time frame: Up to 72 hours

Secondary Outcomes

Decreased Neurological Injury

Neuron Specific Enolase levels

Time frame: Up to 72 hours

Cellular Oxygen Consumption

Cellular (peripheral blood mononuclear cells) oxygen consumption measured with the XFe24 Extracellular Flux Analyzer

Time frame: At 24 hours

Global Oxygen Consumption

VO2 measured using a Compact Anesthesia monitor

Time frame: Up to 48 hours

Mortality

In-hospital mortality

Time frame: 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.

Time frame: At hospital discharge, an average of 14 days

Data from ClinicalTrials.gov

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