Trial Outcomes & Findings for Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest (NCT NCT02934555)

NCT ID: NCT02934555

Last Updated: 2021-02-15

Results Overview

Total (oxidized and reduced form) coenzyme Q10

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 48 participants
• Primary outcome timeframe: Up to 72 hours
• Results posted on: 2021-02-15

Participant Flow

Participant milestones

Measure	Placebo 50 mL of Ensure (a dietary supplement) every 12 hours for 7 days, until neurologic recovery, or until hospital discharge.	Ubiquinol 300 mg of Ubiquinol mixed with 50 mL of Ensure (a dietary supplement) every 12 hours for 7 days, until neurologic recovery, or until hospital discharge.
Overall Study STARTED	23	25
Overall Study COMPLETED	21	22
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest

Baseline characteristics by cohort

Measure	Placebo n=23 Participants 50 mL of Ensure (a dietary supplement) every 12 hours for 7 days, until neurologic recovery, or until hospital discharge.	Ubiquinol n=25 Participants 300 mg of Ubiquinol mixed with 50 mL of Ensure (a dietary supplement) every 12 hours for 7 days, until neurologic recovery, or until hospital discharge.	Total n=48 Participants Total of all reporting groups
Age, Continuous	68 years n=5 Participants	60 years n=7 Participants	62 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Race/Ethnicity, Customized White	12 Participants n=5 Participants	6 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Other	11 Participants n=5 Participants	19 Participants n=7 Participants	30 Participants n=5 Participants
Number of Participants with Shock Shock	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Number of Participants with Shock Non-shock	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 72 hours

Population: Blood samples were not available on all participants at all time-points.

Total (oxidized and reduced form) coenzyme Q10

Outcome measures

Measure	Placebo n=23 Participants 50 mL of Ensure (a dietary supplement) every 12 hours for 7 days, until neurologic recovery, or until hospital discharge.	Ubiquinol n=25 Participants 300 mg of Ubiquinol mixed with 50 mL of Ensure (a dietary supplement) every 12 hours for 7 days, until neurologic recovery, or until hospital discharge.
Coenzyme Q10 Plasma Levels 0 hours	185 ng/mL Interval 120.0 to 267.0	207 ng/mL Interval 125.0 to 348.0
Coenzyme Q10 Plasma Levels 24 hours	113 ng/mL Interval 94.0 to 208.0	441 ng/mL Interval 215.0 to 510.0
Coenzyme Q10 Plasma Levels 48 hours	148 ng/mL Interval 85.0 to 299.0	615 ng/mL Interval 286.0 to 817.0
Coenzyme Q10 Plasma Levels 72 hours	157 ng/mL Interval 102.0 to 169.0	554 ng/mL Interval 380.0 to 1200.0

SECONDARY outcome

Timeframe: Up to 72 hours

Population: Blood samples were not available on all participants at all time-points.

Neuron Specific Enolase levels

Outcome measures

Measure	Placebo n=23 Participants 50 mL of Ensure (a dietary supplement) every 12 hours for 7 days, until neurologic recovery, or until hospital discharge.	Ubiquinol n=25 Participants 300 mg of Ubiquinol mixed with 50 mL of Ensure (a dietary supplement) every 12 hours for 7 days, until neurologic recovery, or until hospital discharge.
Decreased Neurological Injury 0 hours	7.6 ng/mL Interval 5.9 to 10.7	9.2 ng/mL Interval 6.7 to 14.3
Decreased Neurological Injury 24 hours	8.2 ng/mL Interval 4.3 to 19.1	16.8 ng/mL Interval 9.5 to 19.8
Decreased Neurological Injury 48 hours	5.3 ng/mL Interval 2.9 to 9.2	12.6 ng/mL Interval 4.3 to 22.6
Decreased Neurological Injury 72 hours	6.8 ng/mL Interval 4.0 to 14.4	14.4 ng/mL Interval 4.0 to 18.4

SECONDARY outcome

Timeframe: At 24 hours

Population: Cellular oxygen consumption was measured in a subset of the total cohort.

Cellular (peripheral blood mononuclear cells) oxygen consumption measured with the XFe24 Extracellular Flux Analyzer

Outcome measures

Measure	Placebo n=21 Participants 50 mL of Ensure (a dietary supplement) every 12 hours for 7 days, until neurologic recovery, or until hospital discharge.	Ubiquinol n=22 Participants 300 mg of Ubiquinol mixed with 50 mL of Ensure (a dietary supplement) every 12 hours for 7 days, until neurologic recovery, or until hospital discharge.
Cellular Oxygen Consumption Basal OCR	7.6 mL/min/mg Interval 5.5 to 9.0	6.5 mL/min/mg Interval 3.7 to 9.3
Cellular Oxygen Consumption Maximal OCR	20.7 mL/min/mg Interval 16.1 to 34.5	18.0 mL/min/mg Interval 10.8 to 32.0

SECONDARY outcome

Timeframe: Up to 48 hours

Population: Global oxygen consumption was measured in a subset of the total cohort.

VO2 measured using a Compact Anesthesia monitor

Outcome measures

Measure	Placebo n=18 Participants 50 mL of Ensure (a dietary supplement) every 12 hours for 7 days, until neurologic recovery, or until hospital discharge.	Ubiquinol n=14 Participants 300 mg of Ubiquinol mixed with 50 mL of Ensure (a dietary supplement) every 12 hours for 7 days, until neurologic recovery, or until hospital discharge.
Global Oxygen Consumption 24 hours	3.2 mL/min/kg Interval 3.0 to 3.6	3.5 mL/min/kg Interval 2.9 to 4.5
Global Oxygen Consumption 12 hours	3.1 mL/min/kg Interval 2.6 to 3.9	3.5 mL/min/kg Interval 3.0 to 3.9
Global Oxygen Consumption 48 hours	3.8 mL/min/kg Interval 2.9 to 4.8	4.4 mL/min/kg Interval 3.9 to 5.3

SECONDARY outcome

Timeframe: At hospital discharge, an average of 14 days

In-hospital mortality

Outcome measures

Measure	Placebo n=23 Participants 50 mL of Ensure (a dietary supplement) every 12 hours for 7 days, until neurologic recovery, or until hospital discharge.	Ubiquinol n=25 Participants 300 mg of Ubiquinol mixed with 50 mL of Ensure (a dietary supplement) every 12 hours for 7 days, until neurologic recovery, or until hospital discharge.
Mortality	14 Participants	15 Participants

SECONDARY outcome

Timeframe: At hospital discharge, an average of 14 days

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.

Outcome measures

Measure	Placebo n=23 Participants 50 mL of Ensure (a dietary supplement) every 12 hours for 7 days, until neurologic recovery, or until hospital discharge.	Ubiquinol n=25 Participants 300 mg of Ubiquinol mixed with 50 mL of Ensure (a dietary supplement) every 12 hours for 7 days, until neurologic recovery, or until hospital discharge.
Number of Participants With Favorable Neurological Outcome	8 Participants	9 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 14 deaths

Ubiquinol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 15 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Donnino

Beth Israel Deaconess Medical Center

Phone: 6177542882

Email: mdonnino@bidmc.harvard.edu

Results disclosure agreements

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