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

This study is currently recruiting participants.
Verified December 2013 by University of Ottawa Heart Institute
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: December 13, 2013
Last verified: December 2013

November 8, 2013
December 13, 2013
August 2013
August 2016   (final data collection date for primary outcome measure)
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.
  • Neurologic Outcome [ 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.
  • Death [ 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.
Complete list of historical versions of study NCT02011568 on ClinicalTrials.gov Archive Site
  • 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 ]
  • All cause 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.
  • Stroke [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: No ]
    Stroke will be classified as hemorrhagic versus non-hemorrhagic.
  • 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 ]
  • Cardiogenic shock [ Time Frame: During index hospitalization ] [ Designated as safety issue: No ]
  • Repeat circulatory arrest requiring cardiopulmonary resuscitation (CPR) [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Seizures [ Time Frame: During index hospitalization ] [ Designated as safety issue: No ]
  • Renal failure requiring renal replacement therapy [ Time Frame: During index hospitalization ] [ Designated as safety issue: No ]
  • Ventilator associated pneumonia [ Time Frame: During index hospitalization ] [ Designated as safety issue: No ]
  • LV function [ Time Frame: Day 3 and at 90 days ] [ Designated as safety issue: No ]
    LV function assessed by echo.
  • CK release [ Time Frame: Within first 48 hrs ] [ Designated as safety issue: No ]
  • Stent thrombosis [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Discharged home [ Time Frame: Six months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Mild Versus Moderate Therapeutic Hypothermia in Out-of-hospital Cardiac Arrest Patients
Therapeutic Hypothermia Following Out-of-Hospital Cardiac Arrest - A Randomized Trial Comparing Mild and Moderate Therapeutic Hypothermia

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Cardiac Arrest
Other: Therapeutic Hypothermia
  • Moderate hypothermia
    Therapeutic hypothermia at 31 degrees celsius
    Intervention: Other: Therapeutic Hypothermia
  • Active Comparator: Mild Hypothermia
    Therapeutic Hypothermia at 34 degrees Celsius
    Intervention: Other: Therapeutic Hypothermia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
340
Not Provided
August 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Michel R Le May, MD 613 761 4223 mlemay@ottawaheart.ca
Canada
 
NCT02011568
2013106-01
Yes
Michel Le May, University of Ottawa Heart Institute
University of Ottawa Heart Institute
Not Provided
Not Provided
University of Ottawa Heart Institute
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP