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

Not Applicable

Completed

Conditions: Cardiac Arrest

Interventions: Other: Therapeutic Hypothermia

Registration Number: NCT02011568

Lead Sponsor: Ottawa Heart Institute Research Corporation

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 389

Inclusion Criteria

Out of hospital cardiac arrest patient
Return of spontaneous circulation
Glasgow Coma Score equal or lesser than 8.

Exclusion Criteria

Patients residing in a Nursing Home or patients unable to reside independently,
Intracranial bleed responsible for the cardiac arrest,
Severe coagulopathy with clinical evidence of major bleeding,
Coma that is not attributable to cardiac arrest,
Pregnancy,
Life expectancy of < one year due to any cause unrelated to the cardiac arrest,
Known coagulation disorder (i.e. INR >2.0, platelets <100,000 / mm3),
Participation in a study with another investigational device or drug < four weeks,
The Endovascular cooling (ZOLL) device is not available.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate hypothermia	Therapeutic Hypothermia	Therapeutic hypothermia at 31 degrees celsius
Mild Hypothermia	Therapeutic Hypothermia	Therapeutic Hypothermia at 34 degrees Celsius

Primary Outcome Measures

Name	Time	Method
Number of Participants With Death or Poor Neurologic Outcome at 6 Months	Six 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.

Secondary Outcome Measures

Name	Time	Method
Number of Mortality	30 days and 6 months	All cause mortality will be recorded. Mortality will be adjudicated as cardiac versus non-cardiac.
Number of Participants With Stroke	30 days and 6 months	Stroke will be classified as hemorrhagic versus non-hemorrhagic.
Number of Participants With Bleeding	During index hospitalization, up to 40 days	Bleeding will be assessed using the TIMI definition and will be scored as major or minor.
Length of Stay in the Unit	Admission to unit to discharge from unit
Length of Stay in the Hospital	Admission to hospital to discharge from hospital.	The length of stay participant was in hospital (day of admission to day of discharge from facility)
Number of Participants With Cardiogenic Shock	During index hospitalization - day of admission to day of discharge from the facility (*up to 30 days post admission)	The total number of participants who had cardiogenic shock during their admission (day of admission to day of discharge from facility)
Number of Participants With Repeat Circulatory Arrest Requiring Cardiopulmonary Resuscitation (CPR)	Six months
Number of Participants With Seizures	During index hospitalization (*up to 45 days post admission day while in hospital)	Count of participants who had seizures while in hospital (day of admission to day of discharge from the facility)
Number of Participants With Renal Failure Requiring Renal Replacement Therapy	During index hospitalization - day of admission up to 45 days post admission while in hospital	Participants who required renal replacement therapy (e.g. CRRT, IHD)
Number of Participants With Ventilator Associated Pneumonia	During index hospitalization - from day of admission up to 45 days post admission (while in hospital)	The number of participants who developed ventilator associated pneumonia
Number of Participants With Stent Thrombosis	Within 6 months of their admission	Participants who are diagnosed with stent thrombosis
Number of Participants Discharged Home	Six months