Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest

NCT ID: NCT02934555

Last Updated: 2021-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2019-06-02

Brief Summary

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

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.

Conditions

Cardiac Arrest

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Ensure

Intervention Type: DIETARY_SUPPLEMENT

50 mL Ensure

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.

Group Type: EXPERIMENTAL

Ubiquinol

Intervention Type: DRUG

300 mg Ubiquinol (3 mL liquid Ubiquinol).

Ensure

Intervention Type: DIETARY_SUPPLEMENT

50 mL Ensure

Interventions

Ubiquinol

300 mg Ubiquinol (3 mL liquid Ubiquinol).

Intervention Type: DRUG

Ensure

50 mL Ensure

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

CoQ10

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaneka Medical America LLC

INDUSTRY

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Michael Donnino

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael W Donnino, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2015P000319

Identifier Type: -

Identifier Source: org_study_id