SEVOflurane Inhalation in CARdiac Arrest Resuscitated Patients Treated With Therapeutic Hypothermia

Not Applicable

• Conditions: Cardiac Arrest; Therapeutic Hypothermia
• Interventions: Drug: sevoflurane

• Registration Number: NCT02201134
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-16
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-25
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-28
• Last Update Posted: 2016-07-29
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

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
• Contraindication of halogenated anesthesics
• Extra corporeal life support or intra aortic balloon pump

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sevoflurane	sevoflurane	-

Primary Outcome Measures

Name	Time	Method
Determination of the feasibility of a sedation with inhalated sevoflurane in cardiac arrest resuscitated patients	at day 1	The feasibility is evaluated by the number of side effects due to treatment until discharge from hospital.

Secondary Outcome Measures

Name	Time	Method
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	at 3 times: before starting sevoflurane sedation, 24 hours, 48 hours and 72 hours after starting sevoflurane sedation.

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France