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Completed

NCT Number: NCT02934555

Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ubiquinol

Drug

300 mg Ubiquinol (3 mL liquid Ubiquinol).

Other names: CoQ10

Ensure

Dietary Supplement

50 mL Ensure

Primary outcomes

  1. Coenzyme Q10 Plasma Levels

    Time frame: Up to 72 hours

    Total (oxidized and reduced form) coenzyme Q10

Secondary outcomes

  1. Decreased Neurological Injury

    Time frame: Up to 72 hours

    Neuron Specific Enolase levels

  2. Cellular Oxygen Consumption

    Time frame: At 24 hours

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

  3. Global Oxygen Consumption

    Time frame: Up to 48 hours

    VO2 measured using a Compact Anesthesia monitor

  4. Mortality

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

    In-hospital mortality

  5. Number of Participants With Favorable Neurological Outcome

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

    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.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Kaneka Medical America LLC

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 17, 2016
Registry last updated
Feb 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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