Intra-arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest

Study Overview
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Brief Summary
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The aim is to precise the place of therapeutic hypothermia induced before Return of Spontaneous Circulation (ROSC) in pre hospital cardiac arrest. If we find a benefit in terms of biomarkers in inducing in early hypothermia compared to hypothermia induced only after arrival at the hospital, there will be arguments to develop a higher scale study, allowing to prove benefits in terms of survival and neurological status.

Detailed Description
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Principal aim : prove the efficiency of early therapeutic hypothermia induced during ischemia in pre hospital cardiac arrest by a reduction of brain damage biomarkers. Secondary aim: prove the efficiency of early therapeutic induced hypothermia in the reduction of pro-inflammatory cytokines secretion. Determine the number of ROSC, patients survival, neurological status 48 hours after cardiac arrest (GCS) and when leaving the hospital, impact following initial cardiac rhythm and the cooling rate of early therapeutic induced hypothermia.

Official Title
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Intra-arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest. Impact on Biomarker of Brain Damage.

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Procedure: Hypothermia.
* Procedure: No early hypothermia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pre hospital cardiac arrest Exclusion Criteria: under 18 years old pregnancy or breastfeeding women patient under guardianship. not beneficing a social health care system. cardiac arrest of traumatic origin patients with an initial body temperature under 34° C cardiac arrests for which resuscitation maneuvers seem unjustified (DNR criteria)

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Induction of pre hospital early hypothermia in patients having a cardiac . | Procedure: Hypothermia.<br>* Induction of pre hospital therapeutic hypothermia.<br>|
| Active Comparator: 2<br>Induction of hypothermia only at hospital arrival. | Procedure: No early hypothermia<br>* Induction of therapeutic hypothermia only once arrived at hospital.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prove efficacy of early induced hypothermia during ischemia in pre hospital cardiac arrest by a reduction of brain damage biomarkers. |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prove the efficacy of early therapeutic induced hypothermia in the reduction of pro-inflammatory cytokines secretion. |  | 72 hours | 
| Determine the number of Return of Spontaneous Circulation (ROSC), patients survival. |  | 72 hours | 
| Determine neurological status 48 hours after cardiac arrest (GCS) |  | 48 hours | 
| Determine impact following initial cardiac rhythm. |  | 72 hours | 
| Determine the cooling rate of early therapeutic induced hypothermia. |  | 72 hours | 
| Determine neurological status when leaving hospital (or 28 days if not applicable) (CPC) |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypothermia, Cardiac arrest, Biomarkers, Pre hospital cardiac arrest