ClinicalTrials.Veeva

Menu

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

U

University of Ottawa Heart Institute

Status

Completed

Conditions

Cardiac Arrest

Treatments

Other: Therapeutic Hypothermia

Study type

Interventional

Funder types

Other

Identifiers

NCT02011568
2013106-01

Details and patient eligibility

About

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.

Enrollment

360 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

360 participants in 2 patient groups

Moderate hypothermia
Other group
Description:
Therapeutic hypothermia at 31 degrees celsius
Treatment:
Other: Therapeutic Hypothermia
Mild Hypothermia
Active Comparator group
Description:
Therapeutic Hypothermia at 34 degrees Celsius
Treatment:
Other: Therapeutic Hypothermia

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems