Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2007-07-31
2009-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Prehospital hypothermia group
All patients included to the study
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
Interventions
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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 Criteria
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Inclusion Criteria
* remaining comatose and requiring mechanical ventilation
Exclusion Criteria
* 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
ALL
No
Sponsors
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University Hospital Hradec Kralove
OTHER
Emergency Medical Service of the Central Bohemian Region, Czech Republic
OTHER
Responsible Party
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Emergency Medical Service of the Central Bohemian Region, Czech Republic
Principal Investigators
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Roman Skulec, MD
Role: PRINCIPAL_INVESTIGATOR
Emergency Medical Service of the Central Bohemian Region, Czech Republic
Locations
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Emergency Medical Service of the Central Bohemian Region
Beroun, Central Bohemia, Czechia
Hradec Kralove Region Emergency Medical Services, Czech republic
Hradec Králové, Region of Hradec Kralove, Czechia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Related Links
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Web pages of Hradec Kralove Region Emergency Medical Services, Czech republic
Other Identifiers
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SCK-KVK-001
Identifier Type: -
Identifier Source: org_study_id
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