Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Kaneka Medical America LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To study the effects of ubiquinol as a "metabolic resuscitator" in post-cardiac arrest.
Cardiac arrest (CA) occurs in more than 400,000 patients in the United States each year with an estimated mortality of greater than 90%. The majority of patients who are resuscitated from CA will succumb to the neurologic morbidity associated with the post-CA syndrome and ischemic-reperfusion injury. Currently, there are no pharmacologic agents known to offer survival benefit or to prevent devastating neurologic injury in post-CA patients.
A potential therapeutic target following ischemia-reperfusion injury is mitochondrial function in the injured cell and/or reduction of oxygen free radicals. Coenzyme Q10 (CoQ10) is an essential mitochondrial co-factor and free radical scavenger that has been proposed as a neuroprotective agent in various neurodegenerative disorders as well as a cardioprotective agent. CoQ10 have furthermore shown exciting preliminary results as a potential therapy in post-CA.
In order to test the effects of ubiquinol as a "metabolic resuscitator" in post-CA patients and to provide additional preliminary data for a large-scale clinical trial, the investigators are conducting a randomized, double-blind, place-controlled trial of ubiquinol in post-CA patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Patients in the control group will receive a liquid placebo, which is 50 mL of Ensure (a dietary supplement). This will be given every 12 hours for 7 days, until neurologic recovery, or until hospital discharge. |
|
| Ubiquinol | Experimental | Patients in the experimental group will receive 300 mg of Ubiquinol in a liquid mixture. The liquid Ubiquinol will be mixed with 50 mL of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days, until neurologic recovery, or until hospital discharge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ubiquinol | Drug | 300 mg Ubiquinol (3 mL liquid Ubiquinol). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Coenzyme Q10 Plasma Levels | Total (oxidized and reduced form) coenzyme Q10 | Up to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Decreased Neurological Injury | Neuron Specific Enolase levels | Up to 72 hours |
| Cellular Oxygen Consumption | Cellular (peripheral blood mononuclear cells) oxygen consumption measured with the XFe24 Extracellular Flux Analyzer |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael W Donnino, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 50 mL of Ensure (a dietary supplement) every 12 hours for 7 days, until neurologic recovery, or until hospital discharge. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 50 mL of Ensure (a dietary supplement) every 12 hours for 7 days, until neurologic recovery, or until hospital discharge. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Coenzyme Q10 Plasma Levels | Total (oxidized and reduced form) coenzyme Q10 | Blood samples were not available on all participants at all time-points. | Posted | Median | Inter-Quartile Range | ng/mL | Up to 72 hours |
|
From enrolment until hospital discharge.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 50 mL of Ensure (a dietary supplement) every 12 hours for 7 days, until neurologic recovery, or until hospital discharge. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Donnino | Beth Israel Deaconess Medical Center | 6177542882 | mdonnino@bidmc.harvard.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2020 | Dec 20, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C003741 | ubiquinol |
| C024989 | coenzyme Q10 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ensure | Dietary Supplement | 50 mL Ensure |
|
| At 24 hours |
| Global Oxygen Consumption | VO2 measured using a Compact Anesthesia monitor | Up to 48 hours |
| Mortality | In-hospital mortality | At hospital discharge, an average of 14 days |
| Number of Participants With Favorable Neurological Outcome | 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. | At hospital discharge, an average of 14 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Number of Participants with Shock | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Decreased Neurological Injury | Neuron Specific Enolase levels | Blood samples were not available on all participants at all time-points. | Posted | Median | Inter-Quartile Range | ng/mL | Up to 72 hours |
|
|
|
| Secondary | Cellular Oxygen Consumption | Cellular (peripheral blood mononuclear cells) oxygen consumption measured with the XFe24 Extracellular Flux Analyzer | Cellular oxygen consumption was measured in a subset of the total cohort. | Posted | Median | Inter-Quartile Range | mL/min/mg | At 24 hours |
|
|
|
| Secondary | Global Oxygen Consumption | VO2 measured using a Compact Anesthesia monitor | Global oxygen consumption was measured in a subset of the total cohort. | Posted | Median | Inter-Quartile Range | mL/min/kg | Up to 48 hours |
|
|
|
| Secondary | Mortality | In-hospital mortality | Posted | Count of Participants | Participants | At hospital discharge, an average of 14 days |
|
|
|
| Secondary | Number of Participants With Favorable Neurological Outcome | 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. | Posted | Count of Participants | Participants | At hospital discharge, an average of 14 days |
|
|
|
| 14 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | 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. | 15 | 25 | 0 | 25 | 0 | 25 |
Not provided
Not provided
| 24 hours |
|
|
| 48 hours |
|
|
| 72 hours |
|
|
| 48 hours |
|