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

Cardiac Arrest Clinical Trial

— CAPITALCHILL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02011568
• Other study ID #: 2013106-01
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: March 2020

Study information

• Verified date: September 2020
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Hypothermia
• Out-of-Hospital Cardiac Arrest

Intervention

Other:
• Therapeutic Hypothermia

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of mortality	All cause mortality will be recorded. Mortality will be adjudicated as cardiac versus non-cardiac.	30 days and 6 months
Secondary	Number of participants with stroke	Stroke will be classified as hemorrhagic versus non-hemorrhagic.	30 days and 6 months
Secondary	Number of participants with bleeding	Bleeding will be assessed using the TIMI definition and will be scored as major or minor.	During index hospitalization
Secondary	Length of stay in the unit		Admission to unit to discharge from unit
Secondary	Length of stay in the hospital		Admission to hospital to discharge from hospital.
Secondary	Number of participants with cardiogenic shock		During index hospitalization
Secondary	Number of participants with repeat circulatory arrest requiring cardiopulmonary resuscitation (CPR)		Six months
Secondary	Number of participants with seizures		During index hospitalization
Secondary	Number of participants with renal failure requiring renal replacement therapy		During index hospitalization
Secondary	Number of participants with ventilator associated pneumonia		During index hospitalization
Secondary	Number of participants with stent thrombosis		Six months
Secondary	Number of participants discharged home		Six months