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

NCT ID: NCT02011568

Last Updated: 2024-12-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

389 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2020-03-31

Brief Summary

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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

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Conditions

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Cardiac Arrest

Keywords

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Therapeutic Hypothermia Out of hospital cardiac arrest Mild hypothermia Moderate hypothermia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Moderate hypothermia

Therapeutic hypothermia at 31 degrees celsius

Group Type OTHER

Therapeutic Hypothermia

Intervention Type OTHER

Mild Hypothermia

Therapeutic Hypothermia at 34 degrees Celsius

Group Type ACTIVE_COMPARATOR

Therapeutic Hypothermia

Intervention Type OTHER

Interventions

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Therapeutic Hypothermia

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michel R Le May, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Locations

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University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 34665203 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2013106-01

Identifier Type: -

Identifier Source: org_study_id