Clinical trial NCT00915421: Pre-Hospital Cooling in Cardiac Arrest Patients
Official title: Pre-Hospital Cooling in Cardiac Arrest Patients - Feasibility Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Arrest
Keywords: cardiac arrest
therapeutic hypothermia
Postresuscitative disease
Lead sponsor: Emergency Medical Service of the Central Bohemian Region, Czech Republic
Sponsor class: OTHER
Collaborators: name: University Hospital Hradec Kralove
First posted: 2009-06-08
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Out-of-hospital cardiac arrest patients

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.


Eligibility criteria: 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

Primary outcomes:
measure: Effectivity measure - reached cooling rate calculated in °C/30 min
timeFrame: Assessed during prehospital phase
Secondary outcomes:
measure: Appearance of adverse events and complications during prehospital induction of therapeutic mild hypothermia
timeFrame: Assessed during prehospital phase
measure: Achievement of favourable neurological outcome at the hospital discharge
timeFrame: Assessed during prehospital and in-hospital phase
measure: Overall prehospital and in-hospital mortality
timeFrame: Assessed during prehospital and in-hospital phase
measure: The best neurological outcome achieved anytime during hospital stay
timeFrame: Assessed during in-hospital phase
Other outcomes:
Locations:
city: Beroun
country: Czech Republic
facility: Emergency Medical Service of the Central Bohemian Region
state: Central Bohemian region
city: Hradec Kralove
country: Czech Republic
facility: Hradec Kralove Region Emergency Medical Services, Czech republic
state: Region of Hradec Kralove
Study officials:
affiliation: Emergency Medical Service of the Central Bohemian Region, Czech Republic
name: Roman Skulec, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Skulec R, Truhlar A, Seblova J, Dostal P, Cerny V. Pre-hospital cooling of patients following cardiac arrest is effective using even low volumes of cold saline. Crit Care. 2010;14(6):R231. doi: 10.1186/cc9386. Epub 2010 Dec 22.