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Pre-Hospital Cooling in Cardiac Arrest Patients (PRE-COOL)

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ClinicalTrials.gov Identifier: NCT00915421
Recruitment Status : Unknown
Verified June 2009 by Emergency Medical Service of the Central Bohemian Region, Czech Republic.
Recruitment status was:  Recruiting
First Posted : June 8, 2009
Last Update Posted : June 8, 2009
Sponsor:
Collaborator:
University Hospital Hradec Kralove
Information provided by:
Emergency Medical Service of the Central Bohemian Region, Czech Republic

June 5, 2009
June 8, 2009
June 8, 2009
July 2007
July 2009   (Final data collection date for primary outcome measure)
Effectivity measure - reached cooling rate calculated in °C/30 min [ Time Frame: Assessed during prehospital phase ]
Same as current
No Changes Posted
  • Appearance of adverse events and complications during prehospital induction of therapeutic mild hypothermia [ Time Frame: Assessed during prehospital phase ]
  • Achievement of favourable neurological outcome at the hospital discharge [ Time Frame: Assessed during prehospital and in-hospital phase ]
  • Overall prehospital and in-hospital mortality [ Time Frame: Assessed during prehospital and in-hospital phase ]
  • The best neurological outcome achieved anytime during hospital stay [ Time Frame: Assessed during in-hospital phase ]
Same as current
Not Provided
Not Provided
 
Pre-Hospital Cooling in Cardiac Arrest Patients
Pre-Hospital Cooling in Cardiac Arrest Patients - Feasibility Pilot Study

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Out-of-hospital cardiac arrest patients
Cardiac Arrest
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
Prehospital hypothermia group
All patients included to the study
Intervention: Procedure: Induction of therapeutic mild hypothermia
Skulec R, Truhlár A, Seblová J, Dostál P, Cerný 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
40
Same as current
August 2009
July 2009   (Final data collection date for primary outcome measure)

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: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
 
NCT00915421
SCK-KVK-001
Yes
Not Provided
Not Provided
Roman Škulec, Emergency Medical Service of the Central Bohemian Region, Czech Republic
Emergency Medical Service of the Central Bohemian Region, Czech Republic
University Hospital Hradec Kralove
Principal Investigator: Roman Skulec, MD Emergency Medical Service of the Central Bohemian Region, Czech Republic
Emergency Medical Service of the Central Bohemian Region, Czech Republic
June 2009