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

NCT02011568 | Completed Results DMC

• 1 other identifier: 2013106-01
• Study Type: interventional
• Target: 389
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Number of Mortality

  30 days and 6 months

• Number of Participants With Stroke

  30 days and 6 months

• Number of Participants With Bleeding

  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

  Admission to hospital to discharge from hospital.

Study Arms (2)

Moderate hypothermia

OTHER

Therapeutic hypothermia at 31 degrees celsius

Other: Therapeutic Hypothermia

Mild Hypothermia

ACTIVE COMPARATOR

Therapeutic Hypothermia at 34 degrees Celsius

Other: Therapeutic Hypothermia

Interventions

Therapeutic Hypothermia OTHER

Mild Hypothermia; Moderate hypothermia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Out of hospital cardiac arrest patient
• Return of spontaneous circulation
• Glasgow Coma Score equal or lesser than 8.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, k1y 4w7, Canada

Location

Related Publications (1)

• 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.

  PMID: 34665203 DERIVED

MeSH Terms

Conditions

Heart Arrest; Out-of-Hospital Cardiac Arrest

Interventions

Hypothermia, Induced

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cryotherapy; Therapeutics

Results Point of Contact

• Title: Dr Michel Le May
• Organization: University of Ottawa Heart Institute

mlemay@ottawaheart.ca

613-696-7000

Study Officials

• Michel R Le May, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2013
• First Posted: December 13, 2013
• Study Start: August 1, 2013
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: December 6, 2024
• Results First Posted: December 6, 2024

Record last verified: 2023-10

Locations

CA (1)