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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
389
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Number of Participants With Death or Poor Neurologic Outcome at 6 Months
The primary outcome of the study will be death or poor neurologic outcome at six months. Neurologic outcome will be assessed by a specialist in rehabilitation medicine using the Disability Ratings Scale (DRS. Patients will be judged to have had a poor neurologic outcome if the score on the DRS scale is \>5.
Time frame: Six months
Number of Mortality
All cause mortality will be recorded. Mortality will be adjudicated as cardiac versus non-cardiac.
Time frame: 30 days and 6 months
Number of Participants With Stroke
Stroke will be classified as hemorrhagic versus non-hemorrhagic.
Time frame: 30 days and 6 months
Number of Participants With Bleeding
Bleeding will be assessed using the TIMI definition and will be scored as major or minor.
Time frame: During index hospitalization, up to 40 days
Length of Stay in the Unit
Time frame: Admission to unit to discharge from unit
Length of Stay in the Hospital
The length of stay participant was in hospital (day of admission to day of discharge from facility)
Time frame: Admission to hospital to discharge from hospital.
Number of Participants With Cardiogenic Shock
The total number of participants who had cardiogenic shock during their admission (day of admission to day of discharge from facility)
Time frame: During index hospitalization - day of admission to day of discharge from the facility (*up to 30 days post admission)
Number of Participants With Repeat Circulatory Arrest Requiring Cardiopulmonary Resuscitation (CPR)
Time frame: Six months
Number of Participants With Seizures
Count of participants who had seizures while in hospital (day of admission to day of discharge from the facility)
Time frame: During index hospitalization (*up to 45 days post admission day while in hospital)
Number of Participants With Renal Failure Requiring Renal Replacement Therapy
Participants who required renal replacement therapy (e.g. CRRT, IHD)
Time frame: During index hospitalization - day of admission up to 45 days post admission while in hospital
Number of Participants With Ventilator Associated Pneumonia
The number of participants who developed ventilator associated pneumonia
Time frame: During index hospitalization - from day of admission up to 45 days post admission (while in hospital)
Number of Participants With Stent Thrombosis
Participants who are diagnosed with stent thrombosis
Time frame: Within 6 months of their admission
Number of Participants Discharged Home
Time frame: Six months
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