Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest

Beth Israel Lahey Health

Status and phase: Completed; Phase 2

Conditions: Cardiac Arrest

Treatments: Dietary Supplement: Ensure; Drug: Ubiquinol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02934555

2015P000319

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Ensure

Ubiquinol

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Ensure

Drug: Ubiquinol