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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 mortality

Number 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

Page last updated: August 20, 2015

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