Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest
Primary Purpose
Cardiac Arrest
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ubiquinol
Ensure
Sponsored by
About this trial
This is an interventional other trial for Cardiac Arrest
Eligibility Criteria
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)
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
Ubiquinol
Arm 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.
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.
Outcomes
Primary Outcome Measures
Coenzyme Q10 Plasma Levels
Total (oxidized and reduced form) coenzyme Q10
Secondary Outcome Measures
Decreased Neurological Injury
Neuron Specific Enolase levels
Cellular Oxygen Consumption
Cellular (peripheral blood mononuclear cells) oxygen consumption measured with the XFe24 Extracellular Flux Analyzer
Global Oxygen Consumption
VO2 measured using a Compact Anesthesia monitor
Mortality
In-hospital mortality
Number of Participants With Favorable Neurological Outcome
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.
Full Information
NCT ID
NCT02934555
First Posted
January 18, 2016
Last Updated
January 26, 2021
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Kaneka Medical America LLC
1. Study Identification
Unique Protocol Identification Number
NCT02934555
Brief Title
Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest
Official Title
Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
May 25, 2019 (Actual)
Study Completion Date
June 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Kaneka Medical America LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Ubiquinol
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Ubiquinol
Other Intervention Name(s)
CoQ10
Intervention Description
300 mg Ubiquinol (3 mL liquid Ubiquinol).
Intervention Type
Dietary Supplement
Intervention Name(s)
Ensure
Intervention Description
50 mL Ensure
Primary Outcome Measure Information:
Title
Coenzyme Q10 Plasma Levels
Description
Total (oxidized and reduced form) coenzyme Q10
Time Frame
Up to 72 hours
Secondary Outcome Measure Information:
Title
Decreased Neurological Injury
Description
Neuron Specific Enolase levels
Time Frame
Up to 72 hours
Title
Cellular Oxygen Consumption
Description
Cellular (peripheral blood mononuclear cells) oxygen consumption measured with the XFe24 Extracellular Flux Analyzer
Time Frame
At 24 hours
Title
Global Oxygen Consumption
Description
VO2 measured using a Compact Anesthesia monitor
Time Frame
Up to 48 hours
Title
Mortality
Description
In-hospital mortality
Time Frame
At hospital discharge, an average of 14 days
Title
Number of Participants With Favorable Neurological Outcome
Description
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.
Time Frame
At hospital discharge, an average of 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael W Donnino, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest
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