Clinical trial NCT00886184: Intra-arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest
Official title: Intra-arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest. Impact on Biomarker of Brain Damage.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: Hypothermia
Cardiac arrest
Biomarkers
Pre hospital cardiac arrest
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2009-04-22
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Prove efficacy of early induced hypothermia during ischemia in pre hospital cardiac arrest by a reduction of brain damage biomarkers.
timeFrame: 72 hours
Secondary outcomes:
measure: Prove the efficacy of early therapeutic induced hypothermia in the reduction of pro-inflammatory cytokines secretion.
timeFrame: 72 hours
measure: Determine the number of Return of Spontaneous Circulation (ROSC), patients survival.
timeFrame: 72 hours
measure: Determine neurological status 48 hours after cardiac arrest (GCS)
timeFrame: 48 hours
measure: Determine impact following initial cardiac rhythm.
timeFrame: 72 hours
measure: Determine the cooling rate of early therapeutic induced hypothermia.
timeFrame: 72 hours
measure: Determine neurological status when leaving hospital (or 28 days if not applicable) (CPC)
timeFrame: 28 days
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
Study officials:
affiliation: Emergency department - Mobile Intensive Care Unit
name: Guillaume DEBATY, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferreira Da Silva IR, Frontera JA. Targeted temperature management in survivors of cardiac arrest. Cardiol Clin. 2013 Nov;31(4):637-55, ix. doi: 10.1016/j.ccl.2013.07.010.