Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest

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

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest
• Intervention / Treatment: Dietary supplement: Ensure; Drug: Ubiquinol

Detailed Description

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
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Control; 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; 50 mL Ensure
EXPERIMENTAL: Ubiquinol; 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.	Dietary supplement: Ensure; 50 mL Ensure; Drug: Ubiquinol; 300 mg Ubiquinol (3 mL liquid Ubiquinol).; Other Names: CoQ10

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Kaneka Medical America LLC

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (ACTUAL): May 25, 2019
• Study Completion (ACTUAL): June 2, 2019

Study Registration Dates

• First Submitted: January 18, 2016
• First Submitted That Met QC Criteria: October 14, 2016
• First Posted (ESTIMATE): October 17, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: 2015P000319