Cardiac Arrest
Conditions
Keywords
Hypothermia, Cardiac arrest, Biomarkers, Pre hospital cardiac arrest
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.
Interventions
PROCEDUREHypothermia.
Induction of pre hospital therapeutic hypothermia.
PROCEDURENo early hypothermia
Induction of therapeutic hypothermia only once arrived at hospital.
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prove efficacy of early induced hypothermia during ischemia in pre hospital cardiac arrest by a reduction of brain damage biomarkers. | 72 hours |
Secondary
| Measure | Time frame |
|---|---|
| Determine the number of Return of Spontaneous Circulation (ROSC), patients survival. | 72 hours |
| Determine neurological status 48 hours after cardiac arrest (GCS) | 48 hours |
| Prove the efficacy of early therapeutic induced hypothermia in the reduction of pro-inflammatory cytokines secretion. | 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 |
| Determine impact following initial cardiac rhythm. | 72 hours |
Countries
France
Outcome results
None listed