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Coenzyme Q10 in Post-Cardiac Arrest Cerebral Resuscitation

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ClinicalTrials.gov Identifier: NCT01319110
Recruitment Status : Completed
First Posted : March 21, 2011
Results First Posted : April 28, 2017
Last Update Posted : July 31, 2017
Sponsor:
Information provided by (Responsible Party):
Michael N. Cocchi, MD, Beth Israel Deaconess Medical Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Cardiac Arrest
Sudden Cardiac Arrest
Interventions: Drug: Coenzyme Q10
Dietary Supplement: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
CoenzymeQ10

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.

Coenzyme Q10: 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.

Placebo

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.

Placebo: Patients will be given Chocolate Ensure via NG/ OG 3x daily as a placebo.


Participant Flow:   Overall Study
    CoenzymeQ10   Placebo
STARTED   5   5 
COMPLETED   5   5 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
CoenzymeQ10

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.

Coenzyme Q10: 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.

Placebo

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.

Placebo: Patients will be given Chocolate Ensure via NG/ OG 3x daily as a placebo.

Total Total of all reporting groups

Baseline Measures
   CoenzymeQ10   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   5   10 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      4  80.0%      5 100.0%      9  90.0% 
>=65 years      1  20.0%      0   0.0%      1  10.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1  20.0%      2  40.0%      3  30.0% 
Male      4  80.0%      3  60.0%      7  70.0% 


  Outcome Measures

1.  Primary:   Prevalence of Low Serum CoQ10 Levels in Cardiac Arrest Patients   [ Time Frame: Baseline ]

2.  Secondary:   Comparison of Serum CoQ10 Levels Randomized to Supplementation vs. Placebo   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Michael Cocchi
Organization: Beth Israel Deaconess Medical Center
e-mail: mcocchi@bidmc.harvard.edu



Responsible Party: Michael N. Cocchi, MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01319110     History of Changes
Other Study ID Numbers: 2010P000362
First Submitted: March 18, 2011
First Posted: March 21, 2011
Results First Submitted: March 20, 2017
Results First Posted: April 28, 2017
Last Update Posted: July 31, 2017