Pre-Hospital Cooling in Cardiac Arrest Patients

Study Overview
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Brief Summary
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Type of study: Pilot prospective nonrandomized feasibility clinical study. Aim of the study: To assess the feasibility of pre-hospital therapeutic mild hypothermia in patients successfully resuscitated from out-of-hospital cardiac arrest in the setting of prehospital and hospital care in Czech republic. Evaluated hypothesis: Pre-hospital initiation of therapeutic mild hypothermia by rapid administration of intravenous bolus of cold crystalloids is simple, safe, effective and is a feasible procedure to significantly decrease body core temperature during patient's transport to the hospital in Czech republic. The study is observational and does not evaluate any new drug, therapeutic procedure or diagnostic procedure. It is evaluating a known therapeutic procedure, therapeutic mild hypothermia, induced by known technique, cold crystalloid infusion, widely accepted in hospital-related postresuscitative care. However, even its prehospital usage has been published.

Official Title
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Pre-Hospital Cooling in Cardiac Arrest Patients - Feasibility Pilot Study

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Procedure: Induction of therapeutic mild hypothermia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients resuscitated from out-of-hospital cardiac arrest remaining comatose and requiring mechanical ventilation Exclusion Criteria: cardiac arrest of traumatic etiology patient conscious after short cardiopulmonary resuscitation coma of other origin than cardiac arrest (e.g., epileptic paroxysm, intoxication etc.) severe acute heart failure accidental hypothermia below 30°C bradycardia requiring transcutaneous cardiac pacing status Do Not Resuscitate or Do Not Intubate severe circulatory shock severe life threatening cardiac arrhythmias severe and life threatening bleeding severe sepsis any common opinion of intervening team of unfitness of induction of therapeutic mild hypothermia
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prehospital hypothermia group<br>All patients included to the study | Procedure: Induction of therapeutic mild hypothermia<br>* Rapid administration of 4°C cold normal saline to the peripheral vein, dose 5 - 30 ml/kg, to decrease body core temperature below 34°C<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectivity measure - reached cooling rate calculated in °C/30 min |  | Assessed during prehospital phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appearance of adverse events and complications during prehospital induction of therapeutic mild hypothermia |  | Assessed during prehospital phase | 
| Achievement of favourable neurological outcome at the hospital discharge |  | Assessed during prehospital and in-hospital phase | 
| Overall prehospital and in-hospital mortality |  | Assessed during prehospital and in-hospital phase | 
| The best neurological outcome achieved anytime during hospital stay |  | Assessed during in-hospital phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac arrest, therapeutic hypothermia, Postresuscitative disease