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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Ottawa Heart Institute Research Corporation
Sponsor:
Information provided by (Responsible Party):
Michel Le May, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT02011568
First received: November 8, 2013
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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 Intervention
Cardiac Arrest
Other: Therapeutic Hypothermia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Therapeutic Hypothermia Following Out-of-Hospital Cardiac Arrest - A Randomized Trial Comparing Mild and Moderate Therapeutic Hypothermia

Resource links provided by NLM:


Further study details as provided by Ottawa Heart Institute Research Corporation:

Primary Outcome Measures:
  • Number of participants with death or poor neurologic outcome at 6 months [ Time Frame: Six months ] [ Designated as safety issue: No ]
    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:
  • Number of mortality [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: No ]
    All cause mortality will be recorded. Mortality will be adjudicated as cardiac versus non-cardiac.

  • Number of participants with stroke [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: No ]
    Stroke will be classified as hemorrhagic versus non-hemorrhagic.

  • Number of participants with bleeding [ Time Frame: During index hospitalization ] [ Designated as safety issue: No ]
    Bleeding will be assessed using the TIMI definition and will be scored as major or minor.

  • Length of stay in the unit [ Time Frame: Admission to unit to discharge from unit ] [ Designated as safety issue: No ]
  • Length of stay in the hospital [ Time Frame: Admission to hospital to discharge from hospital. ] [ Designated as safety issue: No ]
  • Number of participants with cardiogenic shock [ Time Frame: During index hospitalization ] [ Designated as safety issue: No ]
  • Number of participants with repeat circulatory arrest requiring cardiopulmonary resuscitation (CPR) [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Number of participants with seizures [ Time Frame: During index hospitalization ] [ Designated as safety issue: No ]
  • Number of participants with renal failure requiring renal replacement therapy [ Time Frame: During index hospitalization ] [ Designated as safety issue: No ]
  • Number of participants with ventilator associated pneumonia [ Time Frame: During index hospitalization ] [ Designated as safety issue: No ]
  • Number of participants with stent thrombosis [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Number of participants discharged home [ Time Frame: Six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 340
Study Start Date: August 2013
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Moderate hypothermia
Therapeutic hypothermia at 31 degrees celsius
Other: Therapeutic Hypothermia
Active Comparator: Mild Hypothermia
Therapeutic Hypothermia at 34 degrees Celsius
Other: Therapeutic Hypothermia

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02011568

Contacts
Contact: Michel R Le May, MD 613 761 4223 mlemay@ottawaheart.ca

Locations
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, k1y 4w7
Contact: Michel R Le May, MD    613 761 4223    mlemay@ottawaheart.ca   
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
  More Information

No publications provided

Responsible Party: Michel Le May, medical doctor, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier: NCT02011568     History of Changes
Other Study ID Numbers: 2013106-01
Study First Received: November 8, 2013
Last Updated: July 2, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Heart Institute Research Corporation:
Therapeutic Hypothermia
Out of hospital cardiac arrest
Mild hypothermia
Moderate hypothermia

Additional relevant MeSH terms:
Hypothermia
Heart Arrest
Out-of-Hospital Cardiac Arrest
Body Temperature Changes
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014