Trial Outcomes & Findings for Coenzyme Q10 in Post-Cardiac Arrest Cerebral Resuscitation (NCT NCT01319110)

NCT ID: NCT01319110

Last Updated: 2017-07-31

Results Overview

The primary outcome will be describing the prevalence of low serum CoQ10 levels compared to standard laboratory control values.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2017-07-31

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Coenzyme Q10 in Post-Cardiac Arrest Cerebral Resuscitation

Baseline characteristics by cohort

Measure	CoenzymeQ10 n=5 Participants 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 n=5 Participants 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 n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

The primary outcome will be describing the prevalence of low serum CoQ10 levels compared to standard laboratory control values.

Outcome measures

Measure	CoenzymeQ10 n=5 Participants 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 n=5 Participants 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.
Prevalence of Low Serum CoQ10 Levels in Cardiac Arrest Patients	0.706 ug/mL Standard Deviation 0.290137	0.66 ug/mL Standard Deviation 0.267955

SECONDARY outcome

Timeframe: 1 year

Population: This data was not collected when the study was performed

The secondary outcome will be to compare serum CoQ10 levels among those post-arrest patients randomized to CoQ10 supplementation vs placebo.

Outcome measures

Outcome data not reported

Adverse Events

CoenzymeQ10

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	CoenzymeQ10 n=5 participants at risk 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 n=5 participants at risk 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.
General disorders Death	40.0% 2/5 • Number of events 2	40.0% 2/5 • Number of events 2

Other adverse events

Measure	CoenzymeQ10 n=5 participants at risk 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 n=5 participants at risk 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.
Gastrointestinal disorders Gut suctioning	20.0% 1/5 • Number of events 1	0.00% 0/5

Additional Information

Dr. Michael Cocchi

Beth Israel Deaconess Medical Center

Email: mcocchi@bidmc.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place