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Completed

NCT Number: NCT02011568

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

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.

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Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases Out-of-Hospital Cardiac Arrest

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ottawa Heart Institute

Ottawa, Ontario, k1y 4w7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Therapeutic hypothermia

Other

Primary outcomes

  1. Number of Participants With Death or Poor Neurologic Outcome at 6 Months

    Time frame: 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 outcomes

  1. Number of Mortality

    Time frame: 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

    Time frame: 30 days and 6 months

    Stroke will be classified as hemorrhagic versus non-hemorrhagic.

  3. Number of Participants With Bleeding

    Time frame: During index hospitalization, up to 40 days

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

  4. Length of Stay in the Unit

    Time frame: Admission to unit to discharge from unit

  5. Length of Stay in the Hospital

    Time frame: Admission to hospital to discharge from hospital.

    The length of stay participant was in hospital (day of admission to day of discharge from facility)

  6. Number of Participants With Cardiogenic Shock

    Time frame: During index hospitalization - day of admission to day of discharge from the facility (*up to 30 days post admission)

    The total number of participants who had cardiogenic shock during their admission (day of admission to day of discharge from facility)

  7. Number of Participants With Repeat Circulatory Arrest Requiring Cardiopulmonary Resuscitation (CPR)

    Time frame: Six months

  8. Number of Participants With Seizures

    Time frame: During index hospitalization (*up to 45 days post admission day while in hospital)

    Count of participants who had seizures while in hospital (day of admission to day of discharge from the facility)

  9. Number of Participants With Renal Failure Requiring Renal Replacement Therapy

    Time frame: During index hospitalization - day of admission up to 45 days post admission while in hospital

    Participants who required renal replacement therapy (e.g. CRRT, IHD)

  10. Number of Participants With Ventilator Associated Pneumonia

    Time frame: During index hospitalization - from day of admission up to 45 days post admission (while in hospital)

    The number of participants who developed ventilator associated pneumonia

  11. Number of Participants With Stent Thrombosis

    Time frame: Within 6 months of their admission

    Participants who are diagnosed with stent thrombosis

  12. Number of Participants Discharged Home

    Time frame: Six months

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Official study title

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

Acronym: CAPITALCHILL

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Dec 13, 2013
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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