Clinical trial NCT02934555
Conditions: Cardiac Arrest
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2016-03-01; Completion date: 2019-06-02
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: 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. arm 2: 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.
Interventions: intervention 1: Ubiquinol intervention 2: Ensure
Intervention descriptions: intervention 1: 300 mg Ubiquinol (3 mL liquid Ubiquinol). intervention 2: 50 mL Ensure

Protocol documents:
Prot_SAP_000.pdf: 
 
1 
 
Title:  Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest 
Date:  12/20/2020 
NCT:  
NCT02934555 
 
Study overview: A single-center, prospective, double-blind, randomized, placebo-controlled phase II trial 
comparing oral liquid coenzyme Q10 to placebo after cardiac arrest. Consecutive adult patients who 
present with the following inclusion criteria and meeting none of the exclusion criteria will be 
approached for consent. 
 
Inclusion criteria: 
Exclusion criteria: 
Adult (age ≥ 18 years) 
Cardiac arrest (in- or out-of-hospital) 
Not following commands after ROSC 
Ability to receive enteral medication 
Protected populations  
Current coenzyme Q10 supplementation 
Anticipated death within 24 hours 
> 12 hours from ROSC to randomization 
 
Consent: The legally authorized surrogate of patients who meet all inclusion criteria and no exclusion 
criteria will be approached for written informed consent by members of the investigative team per 
standard procedures and approval from the Institutional Review Board. The study will be performed 
according to the Helsinki declaration.  
 
Randomization and blinding: We will create a master randomization list stratified by the presence of 
shock at the time of randomization (shock defined as use of vasopressors). Patients, clinicians, and the 
research team will remain blinded throughout the full duration of the study. 
 
Treatment protocol: Upon enrollment, demographic data including age, sex, race, and ethnicity, as well 
as vital signs and laboratory data will be recorded. A research assistant will perform venipuncture and 
the blood will be centrifuged and aliquoted into light-protected cryotubes and frozen at minus 80°C. 
After randomization and the initial blood draw, patients will be administered the study drug or placebo 
and will receive two daily dosages for 7 days, until hospital discharge, or until normal neurological 
function. Subsequent blood draws and clinical information will be collected at 24, 48 and 72 hours after 
the initial draw. Patients will be followed to hospital discharge for clinical outcomes. 
 
Dosage regimen: For dose, we will be providing 300 mg of ubiquinol (active coenzyme Q10) every 12 
hours. Any adverse events will be reported in real-time to the Institutional Review Board.  
 
Outcomes: The primary outcome will be coenzyme Q10 plasma levels. Secondary outcomes will include 
additional biomarker measurements (including neuron specific enolase), oxygen consumption, and 
clinical outcomes (mortality and neurological outcomes). 
 
Statistical analysis plan: Descriptive statistics will be used to summarize the study population. Our 
primary time-point of interest will be 24 hours after administration of the study drug. As a secondary 
analysis, we will use repeated measures linear models to analyze differences in outcomes over all time-
points (0, 24, 48, and 72 hours). An appropriate variance-covariance structure will be chosen based on 
the Akaike Information Criteria. Right-skewed variables will be log-transformed before these analyses. 
All hypothesis tests will be two-sided and a p-value < 0.05 will be considered significant.