Intra-arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest

University Hospital, Grenoble244 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

244

Conditions

Cardiac Arrest

Interventions

Hypothermia.PROCEDURE

Induction of pre hospital therapeutic hypothermia.

No early hypothermiaPROCEDURE

Induction of therapeutic hypothermia only once arrived at hospital.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

University Hospital Grenoble

Grenoble, France

Outcomes

Primary Outcomes

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

Time frame: 72 hours

Secondary Outcomes

Prove the efficacy of early therapeutic induced hypothermia in the reduction of pro-inflammatory cytokines secretion.

Time frame: 72 hours

Determine the number of Return of Spontaneous Circulation (ROSC), patients survival.

Time frame: 72 hours

Determine neurological status 48 hours after cardiac arrest (GCS)

Time frame: 48 hours

Determine impact following initial cardiac rhythm.

Time frame: 72 hours

Determine the cooling rate of early therapeutic induced hypothermia.

Time frame: 72 hours

Determine neurological status when leaving hospital (or 28 days if not applicable) (CPC)

Time frame: 28 days

Data from ClinicalTrials.gov

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