Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest

NCT02934555 | Completed Phase 2 Results DMC

• 1 other identifier: 2015P000319
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• Coenzyme Q10 Plasma Levels

  Total (oxidized and reduced form) coenzyme Q10

  Up to 72 hours

Secondary Outcomes (5)

• Decreased Neurological Injury

  Up to 72 hours

• Cellular Oxygen Consumption

  At 24 hours

• Global Oxygen Consumption

  Up to 48 hours

• Mortality

  At hospital discharge, an average of 14 days

• Number of Participants With Favorable Neurological Outcome

  At hospital discharge, an average of 14 days

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Ubiquinol

EXPERIMENTAL

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; Dietary Supplement: Ensure

Interventions

Ubiquinol DRUG

300 mg Ubiquinol (3 mL liquid Ubiquinol).

Also known as: CoQ10

Ubiquinol

Ensure DIETARY_SUPPLEMENT

50 mL Ensure

Control; Ubiquinol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Kaneka Medical America LLC: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Heart Arrest

Interventions

ubiquinol; coenzyme Q10

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Michael Donnino
• Organization: Beth Israel Deaconess Medical Center

mdonnino@bidmc.harvard.edu

6177542882

Study Officials

• Michael W Donnino, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: October 17, 2016
• Study Start: March 1, 2016
• Primary Completion: May 25, 2019
• Study Completion: June 2, 2019
• Last Updated: February 15, 2021
• Results First Posted: February 15, 2021

Record last verified: 2021-01

Locations

US (1)