Mild Versus Moderate Therapeutic Hypothermia in Out-of-hospital Cardiac Arrest Patients (CAPITALCHILL)
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.
|Study Design:||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)|
- 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.
- 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.
- Number of participants with stroke [ Time Frame: 30 days and 6 months ]Stroke will be classified as hemorrhagic versus non-hemorrhagic.
- 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.
- Length of stay in the unit [ Time Frame: Admission to unit to discharge from unit ]
- Length of stay in the hospital [ Time Frame: Admission to hospital to discharge from hospital. ]
- Number of participants with cardiogenic shock [ Time Frame: During index hospitalization ]
- Number of participants with repeat circulatory arrest requiring cardiopulmonary resuscitation (CPR) [ Time Frame: Six months ]
- Number of participants with seizures [ Time Frame: During index hospitalization ]
- Number of participants with renal failure requiring renal replacement therapy [ Time Frame: During index hospitalization ]
- Number of participants with ventilator associated pneumonia [ Time Frame: During index hospitalization ]
- Number of participants with stent thrombosis [ Time Frame: Six months ]
- Number of participants discharged home [ Time Frame: Six months ]
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||July 2020|
|Estimated Primary Completion Date:||July 2020 (Final data collection date for primary outcome measure)|
Therapeutic hypothermia at 31 degrees celsius
|Other: Therapeutic Hypothermia|
Active Comparator: Mild Hypothermia
Therapeutic Hypothermia at 34 degrees Celsius
|Other: Therapeutic Hypothermia|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02011568
|Contact: Michel R Le May, MD||613 696 email@example.com|
|Contact: Christina K Osborne, BSc||613-696-7000 ext firstname.lastname@example.org|
|University of Ottawa Heart Institute||Recruiting|
|Ottawa, Ontario, Canada, k1y 4w7|
|Contact: Michel R Le May, MD 613 696 7297 email@example.com|
|Principal Investigator:||Michel R Le May, MD||Ottawa Heart Institute Research Corporation|