Pre-Hospital Cooling in Cardiac Arrest Patients

• Conditions: Cardiac Arrest
• Interventions: Procedure: Induction of therapeutic mild hypothermia

• Registration Number: NCT00915421
• Lead Sponsor: Emergency Medical Service of the Central Bohemian Region, Czech Republic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Status Verified: 2009-06
• Study First Submitted: 2009-06-05
• Study First Submitted QC: 2009-06-05
• Last Update Submitted: 2009-06-05
• Study First Posted: 2009-06-08
• Last Update Posted: 2009-06-08
• Primary Completion: 2009-07
• Study Completion: 2009-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prehospital hypothermia group	Induction of therapeutic mild hypothermia	All patients included to the study

Primary Outcome Measures

Name	Time	Method
Effectivity measure - reached cooling rate calculated in °C/30 min	Assessed during prehospital phase

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Emergency Medical Service of the Central Bohemian Region; 🇨🇿 Beroun, Central Bohemian region, Czech Republic

Hradec Kralove Region Emergency Medical Services, Czech republic; 🇨🇿 Hradec Kralove, Region of Hradec Kralove, Czech Republic