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

Primary Purpose

Cardiac Arrest

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Therapeutic Hypothermia

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Therapeutic Hypothermia, Out of hospital cardiac arrest, Mild hypothermia, Moderate hypothermia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Ottawa Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Moderate hypothermia

Mild Hypothermia

Arm Description

Therapeutic hypothermia at 31 degrees celsius

Therapeutic Hypothermia at 34 degrees Celsius

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of mortality

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

Number of participants with stroke

Stroke will be classified as hemorrhagic versus non-hemorrhagic.

Number of participants with bleeding

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

Length of stay in the unit

Length of stay in the hospital

Number of participants with cardiogenic shock

Number of participants with repeat circulatory arrest requiring cardiopulmonary resuscitation (CPR)

Number of participants with seizures

Number of participants with renal failure requiring renal replacement therapy

Number of participants with ventilator associated pneumonia

Number of participants with stent thrombosis

Number of participants discharged home

Full Information

NCT ID

NCT02011568

First Posted

November 8, 2013

Last Updated

February 8, 2021

Sponsor

Ottawa Heart Institute Research Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02011568

Brief Title

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

Acronym

CAPITALCHILL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

August 2013 (undefined)

Primary Completion Date

March 2020 (Actual)

Study Completion Date

March 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ottawa Heart Institute Research Corporation

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiac Arrest

Keywords

Therapeutic Hypothermia, Out of hospital cardiac arrest, Mild hypothermia, Moderate hypothermia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

360 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Moderate hypothermia

Arm Type

Other

Arm Description

Therapeutic hypothermia at 31 degrees celsius

Arm Title

Mild Hypothermia

Arm Type

Active Comparator

Arm Description

Therapeutic Hypothermia at 34 degrees Celsius

Intervention Type

Other

Intervention Name(s)

Therapeutic Hypothermia

Primary Outcome Measure Information:

Title

Number of participants with death or poor neurologic outcome at 6 months

Description

Time Frame

Six months

Secondary Outcome Measure Information:

Title

Number of mortality

Description

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

Time Frame

30 days and 6 months

Title

Number of participants with stroke

Description

Stroke will be classified as hemorrhagic versus non-hemorrhagic.

Time Frame

30 days and 6 months

Title

Number of participants with bleeding

Description

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

Time Frame

During index hospitalization

Title

Length of stay in the unit

Time Frame

Admission to unit to discharge from unit

Title

Length of stay in the hospital

Time Frame

Admission to hospital to discharge from hospital.

Title

Number of participants with cardiogenic shock

Time Frame

During index hospitalization

Title

Number of participants with repeat circulatory arrest requiring cardiopulmonary resuscitation (CPR)

Time Frame

Six months

Title

Number of participants with seizures

Time Frame

During index hospitalization

Title

Number of participants with renal failure requiring renal replacement therapy

Time Frame

During index hospitalization

Title

Number of participants with ventilator associated pneumonia

Time Frame

During index hospitalization

Title

Number of participants with stent thrombosis

Time Frame

Six months

Title

Number of participants discharged home

Time Frame

Six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michel R Le May, MD

Organizational Affiliation

Ottawa Heart Institute Research Corporation

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Ottawa Heart Institute

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

k1y 4w7

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

34665203

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.

Results Reference

derived

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

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