Pre-Hospital Cooling in Cardiac Arrest Patients (PRE-COOL)
Recruitment status was: Recruiting
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Pre-Hospital Cooling in Cardiac Arrest Patients - Feasibility Pilot Study|
- Effectivity measure - reached cooling rate calculated in °C/30 min [ Time Frame: Assessed during prehospital phase ] [ Designated as safety issue: No ]
- Appearance of adverse events and complications during prehospital induction of therapeutic mild hypothermia [ Time Frame: Assessed during prehospital phase ] [ Designated as safety issue: Yes ]
- Achievement of favourable neurological outcome at the hospital discharge [ Time Frame: Assessed during prehospital and in-hospital phase ] [ Designated as safety issue: No ]
- Overall prehospital and in-hospital mortality [ Time Frame: Assessed during prehospital and in-hospital phase ] [ Designated as safety issue: No ]
- The best neurological outcome achieved anytime during hospital stay [ Time Frame: Assessed during in-hospital phase ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Estimated Study Completion Date:||August 2009|
|Estimated Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Prehospital hypothermia group
All patients included to the study
Procedure: Induction of therapeutic mild hypothermia
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00915421
|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|
|Principal Investigator:||Roman Skulec, MD||Emergency Medical Service of the Central Bohemian Region, Czech Republic|