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NCT00915421 Clinical Trial

Pre-Hospital Cooling in Cardiac Arrest Patients

Cardiac Arrest Clinical Trial

— PRE-COOL  

Official title:
Pre-Hospital Cooling in Cardiac Arrest Patients - Feasibility Pilot Study

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT00915421
Other study ID # SCK-KVK-001
Secondary ID
Status Unknown status
Phase N/A
First received June 5, 2009
Last updated June 5, 2009
Start date July 2007
Est. completion date August 2009

Study information
Verified date June 2009
Source Emergency Medical Service of the Central Bohemian Region, Czech Republic
Contact Roman Skulec, MD
Phone 00420 777577497
Email skulec@email.cz
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Unknown status
Enrollment 40
Est. completion date August 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Czech Republic 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

Sponsors (2)
Lead Sponsor Collaborator
Emergency Medical Service of the Central Bohemian Region, Czech Republic University Hospital Hradec Kralove

Country where clinical trial is conducted

Czech Republic, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effectivity measure - reached cooling rate calculated in °C/30 min Assessed during prehospital phase
Secondary Appearance of adverse events and complications during prehospital induction of therapeutic mild hypothermia Assessed during prehospital phase
Secondary Achievement of favourable neurological outcome at the hospital discharge Assessed during prehospital and in-hospital phase
Secondary Overall prehospital and in-hospital mortality Assessed during prehospital and in-hospital phase
Secondary The best neurological outcome achieved anytime during hospital stay Assessed during in-hospital phase
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