Intra-arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest

Cardiac Arrest Clinical Trial

— HITUPPAC-BIO  

Official title:

Intra-arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest. Impact on Biomarker of Brain Damage.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00886184
• Other study ID #: 0821
• Secondary ID: 2008-A01488-47
• Status: Completed
• Phase: N/A
• First received: April 20, 2009
• Last updated: January 29, 2013
• Start date: February 2009
• Est. completion date: August 2012

Study information

• Verified date: January 2013
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Hypothermia

Intervention

Procedure:
• Hypothermia.
Induction of pre hospital therapeutic hypothermia.
• No early hypothermia
Induction of therapeutic hypothermia only once arrived at hospital.

Locations

Country	Name	City	State
France	University Hospital Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prove efficacy of early induced hypothermia during ischemia in pre hospital cardiac arrest by a reduction of brain damage biomarkers.		72 hours	No
Secondary	Prove the efficacy of early therapeutic induced hypothermia in the reduction of pro-inflammatory cytokines secretion.		72 hours	No
Secondary	Determine the number of Return of Spontaneous Circulation (ROSC), patients survival.		72 hours	No
Secondary	Determine neurological status 48 hours after cardiac arrest (GCS)		48 hours	No
Secondary	Determine impact following initial cardiac rhythm.		72 hours	No
Secondary	Determine the cooling rate of early therapeutic induced hypothermia.		72 hours	No
Secondary	Determine neurological status when leaving hospital (or 28 days if not applicable) (CPC)		28 days	No