Clinical trial NCT02011568: Mild Versus Moderate Therapeutic Hypothermia in Out-of-hospital Cardiac Arrest Patients
Official title: Therapeutic Hypothermia Following Out-of-Hospital Cardiac Arrest - A Randomized Trial Comparing Mild and Moderate Therapeutic Hypothermia (CAPITAL CHILL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: Therapeutic Hypothermia
Out of hospital cardiac arrest
Mild hypothermia
Moderate hypothermia
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2013-12-13
Enrollment: 389
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants With Death or Poor Neurologic Outcome at 6 Months
timeFrame: Six months
Secondary outcomes:
measure: Number of Mortality
timeFrame: 30 days and 6 months
measure: Number of Participants With Stroke
timeFrame: 30 days and 6 months
measure: Number of Participants With Bleeding
timeFrame: During index hospitalization, up to 40 days
measure: Length of Stay in the Unit
timeFrame: Admission to unit to discharge from unit
measure: Length of Stay in the Hospital
timeFrame: Admission to hospital to discharge from hospital.
measure: Number of Participants With Cardiogenic Shock
timeFrame: During index hospitalization - day of admission to day of discharge from the facility (*up to 30 days post admission)
measure: Number of Participants With Repeat Circulatory Arrest Requiring Cardiopulmonary Resuscitation (CPR)
timeFrame: Six months
measure: Number of Participants With Seizures
timeFrame: During index hospitalization (*up to 45 days post admission day while in hospital)
measure: Number of Participants With Renal Failure Requiring Renal Replacement Therapy
timeFrame: During index hospitalization - day of admission up to 45 days post admission while in hospital
measure: Number of Participants With Ventilator Associated Pneumonia
timeFrame: During index hospitalization - from day of admission up to 45 days post admission (while in hospital)
measure: Number of Participants With Stent Thrombosis
timeFrame: Within 6 months of their admission
measure: Number of Participants Discharged Home
timeFrame: Six months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Michel R Le May, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Le May M, Osborne C, Russo J, So D, Chong AY, Dick A, Froeschl M, Glover C, Hibbert B, Marquis JF, De Roock S, Labinaz M, Bernick J, Marshall S, Maze R, Wells G. Effect of Moderate vs Mild Therapeutic Hypothermia on Mortality and Neurologic Outcomes in Comatose Survivors of Out-of-Hospital Cardiac Arrest: The CAPITAL CHILL Randomized Clinical Trial. JAMA. 2021 Oct 19;326(15):1494-1503. doi: 10.1001/jama.2021.15703.