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

Study Overview
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Brief Summary
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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.

Official Title
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Therapeutic Hypothermia Following Out-of-Hospital Cardiac Arrest - A Randomized Trial Comparing Mild and Moderate Therapeutic Hypothermia (CAPITAL CHILL)

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Other: Therapeutic Hypothermia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Out of hospital cardiac arrest patient Return of spontaneous circulation Glasgow Coma Score equal or lesser than 8. Exclusion Criteria: Patients residing in a Nursing Home or patients unable to reside independently, Intracranial bleed responsible for the cardiac arrest, Severe coagulopathy with clinical evidence of major bleeding, Coma that is not attributable to cardiac arrest, Pregnancy, Life expectancy of < one year due to any cause unrelated to the cardiac arrest, Known coagulation disorder (i.e. INR >2.0, platelets <100,000 / mm3), Participation in a study with another investigational device or drug < four weeks, The Endovascular cooling (ZOLL) device is not available.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Moderate hypothermia<br>Therapeutic hypothermia at 31 degrees celsius | Other: Therapeutic Hypothermia<br> <br> |
| Active Comparator: Mild Hypothermia<br>Therapeutic Hypothermia at 34 degrees Celsius | Other: Therapeutic Hypothermia<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with death or poor neurologic outcome at 6 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. | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of mortality | All cause mortality will be recorded. Mortality will be adjudicated as cardiac versus non-cardiac. | 30 days and 6 months | 
| Number of participants with stroke | Stroke will be classified as hemorrhagic versus non-hemorrhagic. | 30 days and 6 months | 
| Number of participants with bleeding | Bleeding will be assessed using the TIMI definition and will be scored as major or minor. | During index hospitalization | 
| Length of stay in the unit |  | Admission to unit to discharge from unit | 
| Length of stay in the hospital |  | Admission to hospital to discharge from hospital. | 
| Number of participants with cardiogenic shock |  | During index hospitalization | 
| Number of participants with repeat circulatory arrest requiring cardiopulmonary resuscitation (CPR) |  | Six months | 
| Number of participants with seizures |  | During index hospitalization | 
| Number of participants with renal failure requiring renal replacement therapy |  | During index hospitalization | 
| Number of participants with ventilator associated pneumonia |  | During index hospitalization | 
| Number of participants with stent thrombosis |  | Six months | 
| Number of participants discharged home |  | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic Hypothermia, Out of hospital cardiac arrest, Mild hypothermia, Moderate hypothermia