SEVOflurane Inhalation in CARdiac Arrest Resuscitated Patients Treated With Therapeutic Hypothermia

University Hospital, Clermont-Ferrand1 site in 1 country20 target enrollmentJuly 1, 2014

ConditionsCardiac Arrest Therapeutic Hypothermia

Interventionssevoflurane

Drugssevoflurane

Overview

Phase: Not Applicable
Intervention: sevoflurane
Conditions: Cardiac Arrest
Sponsor: University Hospital, Clermont-Ferrand
Enrollment: 20
Locations: 1
Primary Endpoint: Determination of the feasibility of a sedation with inhalated sevoflurane in cardiac arrest resuscitated patients
Status: Completed
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Studying the feasibility of an initial sedation with inhalated sevoflurane during therapeutic hypothermia of cardiac arrests resuscitated patients.

Detailed Description

Prospective clinical study in ICU with ventilated patients sedated with sevoflurane using the Mirus® and Anaconda® , establishing the feasibility of an initial sedation of patients resuscitated from cardiac arrest and treated with therapeutic hypothermia.

Registry

clinicaltrials.gov

Start Date

July 1, 2014

End Date

December 1, 2017

Last Updated

9 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Hospital, Clermont-Ferrand

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•-Adult patients ventilated requiring therapeutic hypothermia in ICU
•Stable respiratory and hemodynamic conditions
•Epinephrine and norepinephrine infusion rate \< 1,5 g/kg/min
•Consent of patients or family
•Arterial line
•Patients resuscitated after cardiac arrest
•No Flow \< 10 min
•Low Flow \< 20 min
•Neutropenia \< 1 G/L
•Post traumatic cardiac arrest

Exclusion Criteria

•-Pregnant woman
•Hemodynamic instability
•Brain death defined by the disappearance of brain stem reflexes

Arms & Interventions

sevoflurane

Intervention: sevoflurane

Outcomes

Primary Outcomes

Determination of the feasibility of a sedation with inhalated sevoflurane in cardiac arrest resuscitated patients

Time Frame: at day 1

The feasibility is evaluated by the number of side effects due to treatment until discharge from hospital.

Secondary Outcomes

Determination of systemic complications and organ failures during hospitalisation(at day 1)
Determination of neurological prognostic of patients at ICU and hospital discharge(at day 1)
Evaluation of systemic inflammation and evolution with cytokines(at day 1)
Evaluation of markers specific of brain ischemia (S100 protein and neuron-specific enolase)(at day 1)