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

NCT02011568 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 389

Last updated 2024-12-06

Study results available
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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.

Conditions

  • Cardiac Arrest

Interventions

OTHER

Therapeutic Hypothermia

Sponsors & Collaborators

  • Ottawa Heart Institute Research Corporation

    lead OTHER

Principal Investigators

  • Michel R Le May, MD · Ottawa Heart Institute Research Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02011568 on ClinicalTrials.gov