Cardiac ArrestPhase 2NCT02934555
Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest
A Phase 2 study testing Ubiquinol and Ensure in people with Cardiac Arrest, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
To study the effects of ubiquinol as a "metabolic resuscitator" in post-cardiac arrest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Ubiquinol and Ensure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 2 Jun 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥ 18 years)
- Cardiac arrest defined by cessation of pulse requiring chest compressions
- Not following commands after ROSC
- Admission to the ICU
- Naso/orogastric tube
- Ability to receive enteral medication
Who cannot join
- Protected populations (pregnant women, prisoners, the intellectual disabled)
- Current CoQ10 supplementation
- Anticipated death within 24 hours
- > 12 hours from ROSC to estimated randomization
- Jejunostomy tube (J-tube)
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
To study the effects of ubiquinol as a "metabolic resuscitator" in post-cardiac arrest.
Read the detailed description
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.
- Conditions
- Cardiac Arrest
- Being tested
- Ubiquinol, Ensure
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UbiquinolDrug
Also called CoQ10
300 mg Ubiquinol (3 mL liquid Ubiquinol).
EnsureDietary supplement
50 mL Ensure
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Ensure |
| 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. Receives: Drug: Ubiquinol; Dietary Supplement: Ensure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coenzyme Q10 Plasma Levels
Total (oxidized and reduced form) coenzyme Q10
Measured: Up to 72 hours
Secondary outcomes (5)
Decreased Neurological Injury
Neuron Specific Enolase levels
Measured: Up to 72 hours
Cellular Oxygen Consumption
Cellular (peripheral blood mononuclear cells) oxygen consumption measured with the XFe24 Extracellular Flux Analyzer
Measured: At 24 hours
Global Oxygen Consumption
VO2 measured using a Compact Anesthesia monitor
Measured: Up to 48 hours
Mortality
In-hospital mortality
Measured: 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.
Measured: At hospital discharge, an average of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startMar 2016
- Primary completion25 May 2019
- Study completion2 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kaneka Medical America LLC
- Responsible party
- Principal investigator, Michael Donnino, Beth Israel Deaconess Medical Center
- Investigators
- Michael W Donnino, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934555
- Sponsor's protocol ID
- 2015P000319
- Status last verified
- Jan 2021
- First submitted
- 18 Jan 2016
- Last updated
- 15 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest
- ClinicalTrials.gov ID
- NCT02934555
- Acronym / sponsor ID
- 2015P000319
- Conditions
- Cardiac Arrest
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Kaneka Medical America LLC
- Study start
- Mar 2016
- Primary completion
- 25 May 2019 (actual)
- Study completion
- 2 Jun 2019 (actual)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Posted 15 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the effects of ubiquinol as a "metabolic resuscitator" in post-cardiac arrest.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: EnsurePatients 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 | Drug: Ubiquinol, Dietary Supplement: EnsurePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult (≥ 18 years)
- Cardiac arrest defined by cessation of pulse requiring chest compressions
- Not following commands after ROSC
- Admission to the ICU
- Naso/orogastric tube
Key exclusion criteria (5 listed)
- Protected populations (pregnant women, prisoners, the intellectual disabled)
- Current CoQ10 supplementation
- Anticipated death within 24 hours
- > 12 hours from ROSC to estimated randomization
- Jejunostomy tube (J-tube)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UbiquinolAlso: CoQ10300 mg Ubiquinol (3 mL liquid Ubiquinol). | Drug | Ubiquinol |
| Ensure50 mL Ensure | Dietary supplement | Control, Ubiquinol |
Primary outcome
Coenzyme Q10 Plasma Levels
Time frame: Up to 72 hours
Total (oxidized and reduced form) coenzyme Q10
5 secondary outcomes
Decreased Neurological Injury
Time frame: Up to 72 hours
Cellular Oxygen Consumption
Time frame: At 24 hours
Global Oxygen Consumption
Time frame: Up to 48 hours
Mortality
Time frame: At hospital discharge, an average of 14 days
Number of Participants With Favorable Neurological Outcome
Time frame: At hospital discharge, an average of 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael W Donnino, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ubiquinol and Ensure in people with Cardiac Arrest, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coenzyme Q10 Plasma Levels (time frame: Up to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2021.