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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
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CoenzymeQ10 Placebo
Hide Arm/Group 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.

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.

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.

Period Title: Overall Study
Started 5 5
Completed 5 5
Not Completed 0 0
Arm/Group Title CoenzymeQ10 Placebo Total
Hide Arm/Group 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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 5 5 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
Female
1
  20.0%
2
  40.0%
3
  30.0%
Male
4
  80.0%
3
  60.0%
7
  70.0%
1.Primary Outcome
Title Prevalence of Low Serum CoQ10 Levels in Cardiac Arrest Patients
Hide Description The primary outcome will be describing the prevalence of low serum CoQ10 levels compared to standard laboratory control values.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CoenzymeQ10 Placebo
Hide Arm/Group 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.

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.

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.

Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: ug/mL
0.706  (0.290137) 0.66  (0.267955)
2.Secondary Outcome
Title Comparison of Serum CoQ10 Levels Randomized to Supplementation vs. Placebo
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This data was not collected when the study was performed
Arm/Group Title CoenzymeQ10 Placebo
Hide Arm/Group 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.

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CoenzymeQ10 Placebo
Hide Arm/Group 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.

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.

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.

All-Cause Mortality
CoenzymeQ10 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CoenzymeQ10 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/5 (40.00%)      2/5 (40.00%)    
General disorders     
Death  2/5 (40.00%)  2 2/5 (40.00%)  2
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CoenzymeQ10 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/5 (20.00%)      0/5 (0.00%)    
Gastrointestinal disorders     
Gut suctioning  1/5 (20.00%)  1 0/5 (0.00%)  0
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
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