Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest
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|ClinicalTrials.gov Identifier: NCT02934555|
Recruitment Status : Completed
First Posted : October 17, 2016
Last Update Posted : July 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Arrest||Drug: Ubiquinol Dietary Supplement: Ensure||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||May 25, 2019|
|Actual Study Completion Date :||June 2, 2019|
Placebo Comparator: Control
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
50 mL Ensure
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.
300 mg Ubiquinol (3 mL liquid Ubiquinol).
Other Name: CoQ10
Dietary Supplement: Ensure
50 mL Ensure
- Oral ubiquinol absorption [ Time Frame: Up to 7 days ]
- Decreased neurological injury [ Time Frame: Up to 3 days ]Neuron specific enolase levels 0, 24, 48, and 72 hours after study drug (ubiquinol or placebo) administration
- Cellular oxygen consumption [ Time Frame: Up to 7 days ]Cellular (peripheral blood mononuclear cells) oxygen consumption measured with the XFe24 Extracellular Flux Analyzer
- Global oxygen consumption [ Time Frame: Up to 7 days ]VO2 will be measured with a Compact Anesthesia monitor
- Mortality [ Time Frame: Until hospital discharge, limit 60 days ]
- Neurological outcome [ Time Frame: Until hospital discharge, limit 60 days ]Cerebral Performance Category score to assess neurological outcome at discharge
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02934555
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Michael W Donnino, MD||Beth Israel Deaconess Medical Center|