Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    ubiquinol | Cardiac arrest | United States
Previous Study | Return to List | Next Study

Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02934555
Recruitment Status : Recruiting
First Posted : October 17, 2016
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
Kaneka Pharma America LLC
Information provided by (Responsible Party):
Michael Donnino, Beth Israel Deaconess Medical Center

Brief Summary:
To study the effects of ubiquinol as a "metabolic resuscitator" in post-cardiac arrest.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Drug: Ubiquinol Dietary Supplement: Ensure Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest
Study Start Date : March 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Arm Intervention/treatment
Placebo Comparator: Control
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.
Dietary Supplement: Ensure
50 mL Ensure

Experimental: Ubiquinol
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.
Drug: Ubiquinol
300 mg Ubiquinol (3 mL liquid Ubiquinol).
Other Name: CoQ10

Dietary Supplement: Ensure
50 mL Ensure




Primary Outcome Measures :
  1. Oral ubiquinol absorption [ Time Frame: Up to 7 days ]

Secondary Outcome Measures :
  1. Decreased neurological injury [ Time Frame: Up to 3 days ]
    Neuron specific enolase levels 0, 24, 48, and 72 hours after study drug (ubiquinol or placebo) administration

  2. Cellular oxygen consumption [ Time Frame: Up to 7 days ]
    Cellular (peripheral blood mononuclear cells) oxygen consumption measured with the XFe24 Extracellular Flux Analyzer

  3. Global oxygen consumption [ Time Frame: Up to 7 days ]
    VO2 will be measured with a Compact Anesthesia monitor

  4. Mortality [ Time Frame: Until hospital discharge, limit 60 days ]
  5. Neurological outcome [ Time Frame: Until hospital discharge, limit 60 days ]
    Cerebral Performance Category score to assess neurological outcome at discharge



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02934555


Contacts
Layout table for location contacts
Contact: Michael W Donnino, MD 617-754-2341
Contact: Mathias J Holmberg, MD 617-818-5887 mholmber@bidmc.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Michael W Donnino, MD    617-754-2341      
Contact: Michael McNaughton    978-204-2173    mmcnaugh@bidmc.harvard.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Kaneka Pharma America LLC
Investigators
Layout table for investigator information
Principal Investigator: Michael W Donnino, MD Beth Israel Deaconess Medical Center

Layout table for additonal information
Responsible Party: Michael Donnino, MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02934555     History of Changes
Other Study ID Numbers: 2015P000319
First Posted: October 17, 2016    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Ubiquinone
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs