Mild Versus Moderate Therapeutic Hypothermia in Out-of-hospital Cardiac Arrest Patients
Information source: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiac Arrest
Intervention: Therapeutic Hypothermia (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Ottawa Heart Institute Research Corporation Official(s) and/or principal investigator(s): Michel R Le May, MD, Principal Investigator, Affiliation: Ottawa Heart Institute Research Corporation
Overall contact: Michel R Le May, MD, Phone: 613 761 4223, Email: mlemay@ottawaheart.ca
Summary
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.
Clinical Details
Official title: Therapeutic Hypothermia Following Out-of-Hospital Cardiac Arrest - A Randomized Trial Comparing Mild and Moderate Therapeutic Hypothermia (CAPITAL CHILL)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Number of participants with death or poor neurologic outcome at 6 months
Secondary outcome: Number of mortalityNumber of participants with stroke Number of participants with bleeding Length of stay in the unit Length of stay in the hospital Number of participants with cardiogenic shock Number of participants with repeat circulatory arrest requiring cardiopulmonary resuscitation (CPR) Number of participants with seizures Number of participants with renal failure requiring renal replacement therapy Number of participants with ventilator associated pneumonia Number of participants with stent thrombosis Number of participants discharged home
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Michel R Le May, MD, Phone: 613 761 4223, Email: mlemay@ottawaheart.ca
University of Ottawa Heart Institute, Ottawa, Ontario k1y 4w7, Canada; Recruiting Michel R Le May, MD, Phone: 613 761 4223, Email: mlemay@ottawaheart.ca
Additional Information
Starting date: August 2013
Last updated: June 16, 2015
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