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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Emergency Medical Service of the Central Bohemian Region, Czech Republic.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University Hospital Hradec Kralove
Information provided by:
Emergency Medical Service of the Central Bohemian Region, Czech Republic
ClinicalTrials.gov Identifier:
NCT00915421
First received: June 5, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Cardiac Arrest
Procedure: Induction of therapeutic mild hypothermia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pre-Hospital Cooling in Cardiac Arrest Patients - Feasibility Pilot Study

Resource links provided by NLM:


Further study details as provided by Emergency Medical Service of the Central Bohemian Region, Czech Republic:

Primary Outcome Measures:
  • Effectivity measure - reached cooling rate calculated in °C/30 min [ Time Frame: Assessed during prehospital phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
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)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Out-of-hospital cardiac arrest patients

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915421

Contacts
Contact: Roman Skulec, MD 00420 777577497 skulec@email.cz
Contact: Anatolij Truhlar, MD 00420 495 833 497 atruhlar@seznam.cz

Locations
Czech Republic
Emergency Medical Service of the Central Bohemian Region Recruiting
Beroun, Central Bohemian region, Czech Republic
Contact: Roman Skulec, MD    00420 777 577 497    skulec@email.cz   
Contact: Anatolij Truhlar, MD    00420 495 833 497    atruhlar@seznam.cz   
Principal Investigator: Roman Skulec, MD         
Hradec Kralove Region Emergency Medical Services, Czech republic Recruiting
Hradec Kralove, Region of Hradec Kralove, Czech Republic
Contact: Anatolij Truhlar, MD    00420 495 833 497    atruhlar@seznam.cz   
Contact: Roman Skulec, MD    00420 777 577 497    skulec@email.cz   
Principal Investigator: Anatolij Truhlar, MD         
Sponsors and Collaborators
Emergency Medical Service of the Central Bohemian Region, Czech Republic
University Hospital Hradec Kralove
Investigators
Principal Investigator: Roman Skulec, MD Emergency Medical Service of the Central Bohemian Region, Czech Republic
  More Information

Additional Information:
No publications provided by Emergency Medical Service of the Central Bohemian Region, Czech Republic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roman Škulec, Emergency Medical Service of the Central Bohemian Region, Czech Republic
ClinicalTrials.gov Identifier: NCT00915421     History of Changes
Other Study ID Numbers: SCK-KVK-001
Study First Received: June 5, 2009
Last Updated: June 5, 2009
Health Authority: Czech Republic: Ethics Committee

Keywords provided by Emergency Medical Service of the Central Bohemian Region, Czech Republic:
cardiac arrest
therapeutic hypothermia
Postresuscitative disease

Additional relevant MeSH terms:
Heart Arrest
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 29, 2014