We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Mild Versus Moderate Therapeutic Hypothermia in Out-of-hospital Cardiac Arrest Patients (CAPITALCHILL)

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02011568
Recruitment Status : Completed
First Posted : December 13, 2013
Last Update Posted : February 10, 2021
Information provided by (Responsible Party):
Michel Le May, Ottawa Heart Institute Research Corporation

Brief Summary:

This trial is currently a single-center, randomized, double-blind investigator initiated prospective clinical trial initiated at the University of Ottawa Heart Institute (UOHI). The plan is to expand the trial shortly as a multi-center project. The patients for this study will be recruited amongst comatose survivors of out-of-hospital cardiac arrest (OHCA). The aim of this study is to determine whether neurologic outcomes at six months are improved with moderate (31 degrees Celsius) versus mild (34 degrees Celsius) therapeutic hypothermia (TH) following return of spontaneous circulation (ROSC) in patients suffering OHCA, with ROSC defined as the resumption of sustained perfusing cardiac activity.

The primary outcome will be the proportion of patients experiencing death or a poor neurologic outcome at six months after out of hospital cardiac arrest.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Other: Therapeutic Hypothermia Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Therapeutic Hypothermia Following Out-of-Hospital Cardiac Arrest - A Randomized Trial Comparing Mild and Moderate Therapeutic Hypothermia (CAPITAL CHILL)
Study Start Date : August 2013
Actual Primary Completion Date : March 2020
Actual Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Moderate hypothermia
Therapeutic hypothermia at 31 degrees celsius
Other: Therapeutic Hypothermia
Active Comparator: Mild Hypothermia
Therapeutic Hypothermia at 34 degrees Celsius
Other: Therapeutic Hypothermia

Primary Outcome Measures :
  1. Number of participants with death or poor neurologic outcome at 6 months [ Time Frame: Six months ]
    The primary outcome of the study will be death or poor neurologic outcome at six months. Neurologic outcome will be assessed by a specialist in rehabilitation medicine using the Disability Ratings Scale (DRS. Patients will be judged to have had a poor neurologic outcome if the score on the DRS scale is >5.

Secondary Outcome Measures :
  1. Number of mortality [ Time Frame: 30 days and 6 months ]
    All cause mortality will be recorded. Mortality will be adjudicated as cardiac versus non-cardiac.

  2. Number of participants with stroke [ Time Frame: 30 days and 6 months ]
    Stroke will be classified as hemorrhagic versus non-hemorrhagic.

  3. Number of participants with bleeding [ Time Frame: During index hospitalization ]
    Bleeding will be assessed using the TIMI definition and will be scored as major or minor.

  4. Length of stay in the unit [ Time Frame: Admission to unit to discharge from unit ]
  5. Length of stay in the hospital [ Time Frame: Admission to hospital to discharge from hospital. ]
  6. Number of participants with cardiogenic shock [ Time Frame: During index hospitalization ]
  7. Number of participants with repeat circulatory arrest requiring cardiopulmonary resuscitation (CPR) [ Time Frame: Six months ]
  8. Number of participants with seizures [ Time Frame: During index hospitalization ]
  9. Number of participants with renal failure requiring renal replacement therapy [ Time Frame: During index hospitalization ]
  10. Number of participants with ventilator associated pneumonia [ Time Frame: During index hospitalization ]
  11. Number of participants with stent thrombosis [ Time Frame: Six months ]
  12. Number of participants discharged home [ Time Frame: Six months ]

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

Inclusion Criteria:

  1. Out of hospital cardiac arrest patient
  2. Return of spontaneous circulation
  3. Glasgow Coma Score equal or lesser than 8.

Exclusion Criteria:

  1. Patients residing in a Nursing Home or patients unable to reside independently,
  2. Intracranial bleed responsible for the cardiac arrest,
  3. Severe coagulopathy with clinical evidence of major bleeding,
  4. Coma that is not attributable to cardiac arrest,
  5. Pregnancy,
  6. Life expectancy of < one year due to any cause unrelated to the cardiac arrest,
  7. Known coagulation disorder (i.e. INR >2.0, platelets <100,000 / mm3),
  8. Participation in a study with another investigational device or drug < four weeks,
  9. The Endovascular cooling (ZOLL) device is not available.

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): NCT02011568

Layout table for location information
Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, k1y 4w7
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Layout table for investigator information
Principal Investigator: Michel R Le May, MD Ottawa Heart Institute Research Corporation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Michel Le May, medical doctor, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT02011568    
Other Study ID Numbers: 2013106-01
First Posted: December 13, 2013    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: September 2020
Keywords provided by Michel Le May, Ottawa Heart Institute Research Corporation:
Therapeutic Hypothermia
Out of hospital cardiac arrest
Mild hypothermia
Moderate hypothermia
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes