search
Back to results

Coenzyme Q10 in Post-Cardiac Arrest Cerebral Resuscitation

Primary Purpose

Cardiac Arrest, Sudden Cardiac Arrest

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Coenzyme Q10
Placebo
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Cardiac Arrest, Post Cardiac Arrest, CoQ10, Ubiquinone, Post Arrest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult patients (age > 18 years)
  2. Comatose after CA with subsequent return of spontaneous circulation

Exclusion Criteria:

  1. Comatose status prior to CA
  2. CoQ10 therapy within one month prior to CA
  3. Pregnancy

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CoenzymeQ10

Placebo

Arm Description

Patients will receive CoenzymeQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff.

Patients will receive 20 ml chocolate Ensure (as a placebo) three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). Placebo will be given through pre-existing NG or OG tube.

Outcomes

Primary Outcome Measures

Prevalence of Low Serum CoQ10 Levels in Cardiac Arrest Patients
The primary outcome will be describing the prevalence of low serum CoQ10 levels compared to standard laboratory control values.

Secondary Outcome Measures

Comparison of Serum CoQ10 Levels Randomized to Supplementation vs. Placebo
The secondary outcome will be to compare serum CoQ10 levels among those post-arrest patients randomized to CoQ10 supplementation vs placebo.

Full Information

First Posted
March 18, 2011
Last Updated
July 3, 2017
Sponsor
Beth Israel Deaconess Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01319110
Brief Title
Coenzyme Q10 in Post-Cardiac Arrest Cerebral Resuscitation
Official Title
Coenzyme Q10 in Post-Cardiac Arrest Cerebral Resuscitation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 2011 (Actual)
Primary Completion Date
December 31, 2011 (Actual)
Study Completion Date
December 31, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Specific Aim #1: To determine if levels of CoQ10 are low post-cardiac arrest (CA). We will perform a prospective trial with the primary endpoint of describing the prevalence of low serum CoQ10 levels. Specific Aim #2: To determine if CoQ10 levels in post-CA patients can be increased with the administration of exogenous CoQ10.. We will perform a randomized control trial (RCT) of post-CA patients with the secondary endpoint of comparing CoQ10 levels among those randomized to CoQ10 supplementation vs placebo.
Detailed Description
Cardiac arrest (CA) occurs in nearly 350,000 patients in the U.S. each year with an estimated mortality of 60% in those surviving the initial arrest. Moreover, the overall prognosis for survivors is often limited by neurologic injury. Two randomized control trials (RCTs) have demonstrated that therapeutic hypothermia (TH) after CA improves survival and reduces neurologic morbidity. As a result of these studies, TH has become the standard of care in post-CA patients. The mechanism of action for TH is hypothesized to be a reduction in cerebral oxygen consumption that occurs following an ischemia-reperfusion injury. Another similar potential target following ischemia-reperfusion injury is mitochondrial function in the injured brain cells and attenuation of potentially damaging oxygen-free radicals. Specifically, optimizing mitochondrial function and reducing oxygen free radicals may enhance cellular function and mitigate cellular injury thereby leading to improved neurologic outcomes. Coenzyme Q10 (CoQ10) is an essential mitochondrial co-factor and free radical scavenger that has been found to have neuroprotective effects in various neurodegenerative disorders such as Parkinson's disease and Huntington's disease. Whether CoQ10 can provide neuroprotection in acute ischemia-reperfusion injury remains less clear, but has been recognized by the American Heart Association as a potentially promising neuroprotective agent. We hypothesize that the administration of exogenous CoQ10 will raise serum concentrations of CoQ10 and as such may mitigate the adverse effects of the post-CA ischemia-reperfusion injury on the brain by optimizing mitochondrial function and reducing oxygen-free radicals. We support this hypothesis by the following: Ischemia-reperfusion injury disrupts normal mitochondrial function and increases O2 free radicals. CoQ10 has been found to attenuate the effects of ischemia-reperfusion injury through optimizing mitochondrial function and mitigation of cellular apoptosis. CoQ10 has neuroprotective effects in other neurodegenerative disorders. Our group has unpublished preliminary data showing low CoQ10 levels in a majority of patients with septic shock, and that lower CoQ10 levels are significantly associated with multiple markers of the inflammatory cascade. A pilot human trial in post-CA patients demonstrated a reduction in mortality and trend toward reduction in neurologic morbidity. To test our hypothesis, we propose the following pilot study as proof of concept in preparation for a larger multicenter trial powered toward neurologic outcome and mortality. This pilot study will allow for a more informed power analysis for a larger trial, provide proof of concept for enrollment and administration of therapy, examine the time-frame for drug absorption into serum, and evaluate for tolerability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Sudden Cardiac Arrest
Keywords
Cardiac Arrest, Post Cardiac Arrest, CoQ10, Ubiquinone, Post Arrest

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CoenzymeQ10
Arm Type
Experimental
Arm Description
Patients will receive CoenzymeQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive 20 ml chocolate Ensure (as a placebo) three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). Placebo will be given through pre-existing NG or OG tube.
Intervention Type
Drug
Intervention Name(s)
Coenzyme Q10
Other Intervention Name(s)
Ubiquinone
Intervention Description
Patients will receive CoQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Patients will be given Chocolate Ensure via NG/ OG 3x daily as a placebo.
Primary Outcome Measure Information:
Title
Prevalence of Low Serum CoQ10 Levels in Cardiac Arrest Patients
Description
The primary outcome will be describing the prevalence of low serum CoQ10 levels compared to standard laboratory control values.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Comparison of Serum CoQ10 Levels Randomized to Supplementation vs. Placebo
Description
The secondary outcome will be to compare serum CoQ10 levels among those post-arrest patients randomized to CoQ10 supplementation vs placebo.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients (age > 18 years) Comatose after CA with subsequent return of spontaneous circulation Exclusion Criteria: Comatose status prior to CA CoQ10 therapy within one month prior to CA Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael N Cocchi, 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

Coenzyme Q10 in Post-Cardiac Arrest Cerebral Resuscitation

We'll reach out to this number within 24 hrs