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

Cardiac Arrest research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cardiac Arrest

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Therapeutic Hypothermia

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Moderate hypothermiaTherapeutic hypothermia at 31 degrees celsius

Mild HypothermiaTherapeutic Hypothermia at 34 degrees Celsius

Study Status

Recruiting

Start Date: August 2013

Completed Date: July 2020

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Number of participants with death or poor neurologic outcome at 6 months

Secondary Outcome: Number of mortality

Study sponsors, principal investigator, and references

Principal Investigator: Michel R Le May, MD

Lead Sponsor: Ottawa Heart Institute Research Corporation

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02011568

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