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

University of Ottawa Heart Institute

Status: Completed

Conditions: Cardiac Arrest

Treatments: Other: Therapeutic Hypothermia

Study type: Interventional

Funder types: Other

Identifiers

NCT02011568

2013106-01

Details and patient eligibility

About

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.

Enrollment: 360 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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360 participants in 2 patient groups

Moderate hypothermia

Other group

Description:

Therapeutic hypothermia at 31 degrees celsius

Treatment:

Other: Therapeutic Hypothermia

Mild Hypothermia

Active Comparator group

Description:

Therapeutic Hypothermia at 34 degrees Celsius

Treatment:

Other: Therapeutic Hypothermia