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

• Sponsor: Ottawa Heart Institute Research Corporation (Other)
• Overall Status: Completed
• CT.gov ID: NCT02011568
• Collaborator: (none)
• Enrollment: 360
• Location: 1
• Arms: 2
• Duration (Months): 79
• Patients Per Site Per Month: 4.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest	Other: Therapeutic Hypothermia	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 360 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Therapeutic Hypothermia Following Out-of-Hospital Cardiac Arrest - A Randomized Trial Comparing Mild and Moderate Therapeutic Hypothermia (CAPITAL CHILL)
• Study Start Date: Aug 1, 2013
• Actual Primary Completion Date: Mar 1, 2020
• Actual Study Completion Date: Mar 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Number of mortality [30 days and 6 months]

   All cause mortality will be recorded. Mortality will be adjudicated as cardiac versus non-cardiac.

2. Number of participants with stroke [30 days and 6 months]

   Stroke will be classified as hemorrhagic versus non-hemorrhagic.

3. Number of participants with bleeding [During index hospitalization]

   Bleeding will be assessed using the TIMI definition and will be scored as major or minor.

4. Length of stay in the unit [Admission to unit to discharge from unit]

5. Length of stay in the hospital [Admission to hospital to discharge from hospital.]

6. Number of participants with cardiogenic shock [During index hospitalization]

7. Number of participants with repeat circulatory arrest requiring cardiopulmonary resuscitation (CPR) [Six months]

8. Number of participants with seizures [During index hospitalization]

9. Number of participants with renal failure requiring renal replacement therapy [During index hospitalization]

10. Number of participants with ventilator associated pneumonia [During index hospitalization]

11. Number of participants with stent thrombosis [Six months]

12. Number of participants discharged home [Six months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Ottawa Heart Institute	Ottawa	Ontario	Canada	k1y 4w7

Sponsors and Collaborators

• Ottawa Heart Institute Research Corporation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michel Le May, medical doctor, Ottawa Heart Institute Research Corporation
• ClinicalTrials.gov Identifier: NCT02011568
• Other Study ID Numbers: 2013106-01
• First Posted: Dec 13, 2013
• Last Update Posted: Feb 10, 2021
• Last Verified: Sep 1, 2020

• Keywords provided by Michel Le May, medical doctor, Ottawa Heart Institute Research Corporation: Therapeutic Hypothermia; Out of hospital cardiac arrest; Mild hypothermia; Moderate hypothermia
• Additional relevant MeSH terms: Heart Arrest; Out-of-Hospital Cardiac Arrest; Hypothermia

Study Results

No Results Posted as of Feb 10, 2021