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

Therapeutic Hypothermia Following Out-of-Hospital Cardiac Arrest - A Randomized Trial Comparing Mild and Moderate Therapeutic Hypothermia (CAPITAL CHILL)

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 Overview

• Status: Completed
• Conditions: Cardiac Arrest
• Intervention / Treatment: Other: Therapeutic Hypothermia

• Study Type: Interventional
• Enrollment (Actual): 389
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4W7
      • University of Ottawa Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Moderate hypothermia; Therapeutic hypothermia at 31 degrees celsius	Other: Therapeutic Hypothermia
Active Comparator: Mild Hypothermia; Therapeutic Hypothermia at 34 degrees Celsius	Other: Therapeutic Hypothermia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Mortality	All cause mortality will be recorded. Mortality will be adjudicated as cardiac versus non-cardiac.	30 days and 6 months
Number of Participants With Stroke	Stroke will be classified as hemorrhagic versus non-hemorrhagic.	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.	During index hospitalization, up to 40 days
Length of Stay in the Unit		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)	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)	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)		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)	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)	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	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	Within 6 months of their admission
Number of Participants Discharged Home		Six months

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Investigators: Principal Investigator: Michel R Le May, MD, Ottawa Heart Institute Research Corporation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: November 8, 2013
• First Submitted That Met QC Criteria: December 9, 2013
• First Posted (Estimated): December 13, 2013

Study Record Updates

• Last Update Posted (Actual): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Out of hospital cardiac arrest; Therapeutic Hypothermia; Mild hypothermia; Moderate hypothermia
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Body Temperature Changes; Heart Arrest; Hypothermia; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 2013106-01