Intra-arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest

Not Applicable

Completed

• Conditions: Cardiac Arrest
• Interventions: Procedure: Hypothermia.; Procedure: No early hypothermia

• Registration Number: NCT00886184
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

The aim is to precise the place of therapeutic hypothermia induced before Return of Spontaneous Circulation (ROSC) in pre hospital cardiac arrest. If we find a benefit in terms of biomarkers in inducing in early hypothermia compared to hypothermia induced only after arrival at the hospital, there will be arguments to develop a higher scale study, allowing to prove benefits in terms of survival and neurological status.

Detailed Description

Principal aim : prove the efficiency of early therapeutic hypothermia induced during ischemia in pre hospital cardiac arrest by a reduction of brain damage biomarkers.

Secondary aim: prove the efficiency of early therapeutic induced hypothermia in the reduction of pro-inflammatory cytokines secretion. Determine the number of ROSC, patients survival, neurological status 48 hours after cardiac arrest (GCS) and when leaving the hospital, impact following initial cardiac rhythm and the cooling rate of early therapeutic induced hypothermia.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-04-20
• Study First Submitted QC: 2009-04-21
• Study First Posted: 2009-04-22
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-29
• Last Update Posted: 2013-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 244

Inclusion Criteria

• pre hospital cardiac arrest

Exclusion Criteria

• under 18 years old
• pregnancy or breastfeeding women
• patient under guardianship.
• not beneficing a social health care system.
• cardiac arrest of traumatic origin
• patients with an initial body temperature under 34° C
• cardiac arrests for which resuscitation maneuvers seem unjustified (DNR criteria)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Hypothermia.	Induction of pre hospital early hypothermia in patients having a cardiac .
2	No early hypothermia	Induction of hypothermia only at hospital arrival.

Primary Outcome Measures

Name	Time	Method
Prove efficacy of early induced hypothermia during ischemia in pre hospital cardiac arrest by a reduction of brain damage biomarkers.	72 hours

Secondary Outcome Measures

Name	Time	Method
Prove the efficacy of early therapeutic induced hypothermia in the reduction of pro-inflammatory cytokines secretion.	72 hours
Determine the number of Return of Spontaneous Circulation (ROSC), patients survival.	72 hours
Determine neurological status 48 hours after cardiac arrest (GCS)	48 hours
Determine impact following initial cardiac rhythm.	72 hours
Determine the cooling rate of early therapeutic induced hypothermia.	72 hours
Determine neurological status when leaving hospital (or 28 days if not applicable) (CPC)	28 days

Trial Locations

Locations (1)

University Hospital Grenoble; 🇫🇷 Grenoble, France