NCT00915421

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2007

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 8, 2009

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

June 8, 2009

Status Verified

June 1, 2009

Enrollment Period

2 years

First QC Date

June 5, 2009

Last Update Submit

June 5, 2009

Conditions

Cardiac Arrest

Keywords

cardiac arresttherapeutic hypothermiaPostresuscitative disease

Outcome Measures

Primary Outcomes (1)

  • Effectivity measure - reached cooling rate calculated in °C/30 min

    Assessed during prehospital phase

Secondary Outcomes (4)

  • Appearance of adverse events and complications during prehospital induction of therapeutic mild hypothermia

    Assessed during prehospital phase

  • Achievement of favourable neurological outcome at the hospital discharge

    Assessed during prehospital and in-hospital phase

  • Overall prehospital and in-hospital mortality

    Assessed during prehospital and in-hospital phase

  • The best neurological outcome achieved anytime during hospital stay

    Assessed during in-hospital phase

Study Arms (1)

Prehospital hypothermia group

All patients included to the study

Procedure: Induction of therapeutic mild hypothermia

Interventions

Induction of therapeutic mild hypothermiaPROCEDURE

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Out-of-hospital cardiac arrest patients

You may qualify if:

  • patients resuscitated from out-of-hospital cardiac arrest
  • remaining comatose and requiring mechanical ventilation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emergency Medical Service of the Central Bohemian Region

Beroun, Central Bohemia, Czechia

RECRUITING

Hradec Kralove Region Emergency Medical Services, Czech republic

Hradec Králové, Region of Hradec Kralove, Czechia

RECRUITING

Related Publications (1)

  • 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.

    PMID: 21176218DERIVED

Related Links

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Roman Skulec, MD

    Emergency Medical Service of the Central Bohemian Region, Czech Republic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roman Skulec, MD

CONTACT

00420 777577497skulec@email.cz

Anatolij Truhlar, MD

CONTACT

00420 495 833 497atruhlar@seznam.cz

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 5, 2009

First Posted

June 8, 2009

Study Start

July 1, 2007

Primary Completion

July 1, 2009

Study Completion

August 1, 2009

Last Updated

June 8, 2009

Record last verified: 2009-06

Locations

CZ(2)