Time-differentiated Therapeutic Hypothermia

Study Overview
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Brief Summary
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The purpose of this study is to determine if 48 hours of mild therapeutic hypothermia following out of hospital cardiac arrest gives a better cerebral outcome compared to 24 hours therapeutic hypothermia.

Detailed Description
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Sudden out-of-hospital cardiac arrest (OOH-CA) remains a significant cause of death. However, in 2002 it was in two clinical trials demonstrated that mild therapeutic hypothermia in comatose OOH-CA victims yields a better cerebral outcome measured by Cerebral Performance Category Score (CPC) after 6 month. The optimal mild hypothermia treatment time is however not known. The two trials from 2002 apply the treatment for 12 and 24 hours respectively. In newborns with cerebral hypoxic damage the standard treatment time is 72 hours. It is therefore relevant to investigate the influence of the treatment time on the cerebral outcome in OOH-CA victims. In the present study cerebral outcome after mild therapeutic hypothermia (target temperature 33 degrees centigrade) in OOH-CA patients for 24 is compared to outcome after 48 hours of mild hypothermia. The main outcome parameter is mortality and CPC score measured 6 month after the treatment.

Official Title
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Time-differentiated Treatment With Mild Therapeutic Hypothermia Following Cardiac Arrest, a Multi Center Study.

Conditions
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Out of Hospital Cardiac Arrest

Intervention / Treatment
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* Other: Therapeutic hypothermia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Out of hospital cardiac arrest of suspected cardiac origin Return of spontaneous circulation (ROSC) Glasgow Coma Score < 8 Estimated time interval from cardiac arrest to ROSC ≤ 60 min Exclusion Criteria: OOH-CA of suspected origin other than cardiac In hospital Cardiac arrest Terminal disease Coagulation disorders Unwitnessed asystolia Time from cardiac arrest to start of hypothermia treatment > 240 min GCS ≥ 8 Pregnancy Persistent cardiogenic shock (Systolic blood pressure < 80 mmHg despite inotropic treatment and aortic balloon pump). CPC 3-4 before cardiac arrest Acute intra cerebral bleeding Acute stroke Acute coronary artery bypass grafting

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 24 hours hypothermia<br>24 hours hypothermia | Other: Therapeutic hypothermia<br>* Mild therapeutic hypothermia with a target temperature of 33 degrees Centigrade for 24 or 48 hours<br>|
| Experimental: 48 hours hypothermoa<br>48 hours hypothermia | Other: Therapeutic hypothermia<br>* Mild therapeutic hypothermia with a target temperature of 33 degrees Centigrade for 24 or 48 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPC | CPC = Cerebral Performance Category Score. The primary outcome of the study is analyzed as the proportion of patients with good neurological outcome in the two groups, (CPC 1-2) at 6 months after CA. | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Adverse events are registered during the treatment and until discharge from primary hospital unit | 10 days | 
| CPC at discharge | CPC at discharge from primary hospital unit and after 28 days plus after 3 month | 3 month | 
| Mortality | CPC 5 at 6 month | 6 month |