Hypothermia After In-hospital Cardiac Arrest

Study Overview
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Brief Summary
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ILCOR Recommendations On the basis of the published evidence to date, the Advanced Life Support (ALS) Task Force of the International Liaison Committee on Resuscitation (ILCOR) made the following recommendations in October 2002: Unconscious adult patients with spontaneous circulation after out-of-hospital cardiac arrest should be cooled to 32°C to 34°C for 12 to 24 hours when the initial rhythm was ventricular fibrillation (VF).Such cooling may also be beneficial for other rhythms or in-hospital cardiac arrest (Circulation. 2003;108:118-121). This study ist to investigate the efficacy of mild therapeutic hypothermia on mortality and neurological outcome in patients after in-hospital cardiac arrest.

Detailed Description
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This is a randomized controlled multicenter trial. Patients after in-hospital cardiac arrest are randomized either to standard therapy or to standard therapy in addition to mild therapeutic hypothermia. Mild therapeutic hypothermia is performed for 24 hours with a target temperature of 32-34°C. Inclusion criteria are: Adult patients which have been resuscitated after cardiac arrest in-hospital and who remain unconscious after restoration of spontanous circulation. Exclusion criteria are: severe cardiogenic shock, severe rhythm disorders, major surgery within the last 10 days, planned surgery within the next 24 hours afer resuscitation, active bleeding, suspicion od intracranial bleeding, severe infection, such as pneumonia or sepsis, a severe neurological deficit before cardiac arrest, an aquired immun deficency, pregnacy. The primary endpoint is mortality for all causes after six months. Secondary endpoints are neurological outcome after six months measured by the Glasgow-Pittsburgh Cerebral Performance scale, and in-hospital-mortality.

Official Title
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Hypothermia After In-hospital Cardiac Arrest

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Procedure: Mild therapeutic hypothermia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: in-hospital cardiac arrest restoration of spontanous circulation unconsciousness age over 18 initiation of mild therapeutic hypothermia is possible within 4h after resuscitation Exclusion Criteria: active bleeding suspicion of intra cranial bleeding severe infection aquired immun deficency severe rhythm disorders suspicion of cerebral insult known severe cognotive deficit before the index event pregnancy pre existing disease which makes 6 months survival unlikely

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| No Intervention: Control<br>Standard therapy as used in the hospital's ICU | |
| Active Comparator: Hypothermia<br>Standard therapy as used in the hospital's ICU plus Hypothermia | Procedure: Mild therapeutic hypothermia<br>* Mild therapeutic hypothermia will be performed by any methods applicable in the hospitals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality at 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurological outcome at six months measured by the Glasgow-Pittsburgh cerebral performance scale |  | 6 months | 
| in-hospital all cause mortality |  | time until discharge or death | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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in-hospital cardiac arrest, resuscitation, mild therapeutic hypothermia