Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest

Cardiac Arrest Clinical Trial

Official title:

Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02934555
• Other study ID #: 2015P000319
• Status: Completed
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: June 2, 2019

Study information

• Verified date: January 2021
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2, 2019
• Est. primary completion date: May 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Drug:
• Ubiquinol
300 mg Ubiquinol (3 mL liquid Ubiquinol).

Dietary Supplement:
• Ensure
50 mL Ensure

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Kaneka Pharma America LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coenzyme Q10 Plasma Levels	Total (oxidized and reduced form) coenzyme Q10	Up to 72 hours
Secondary	Decreased Neurological Injury	Neuron Specific Enolase levels	Up to 72 hours
Secondary	Cellular Oxygen Consumption	Cellular (peripheral blood mononuclear cells) oxygen consumption measured with the XFe24 Extracellular Flux Analyzer	At 24 hours
Secondary	Global Oxygen Consumption	VO2 measured using a Compact Anesthesia monitor	Up to 48 hours
Secondary	Mortality	In-hospital mortality	At hospital discharge, an average of 14 days
Secondary	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