SEVOflurane Inhalation in CARdiac Arrest Resuscitated Patients Treated With Therapeutic Hypothermia

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2016

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.

Interventions

  • Drug: sevoflurane

Arms, Groups and Cohorts

  • Other: sevoflurane

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Determination of neurological prognostic of patients at ICU and hospital discharge
    • Time Frame: at day 1
  • Determination of systemic complications and organ failures during hospitalisation
    • Time Frame: at day 1
  • Evaluation of systemic inflammation and evolution with cytokines
    • Time Frame: at day 1
  • Evaluation of markers specific of brain ischemia (S100 protein and neuron-specific enolase)
    • Time Frame: at day 1
    • at 3 times: before starting sevoflurane sedation, 24 hours, 48 hours and 72 hours after starting sevoflurane sedation.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Clermont-Ferrand
  • Collaborator
    • University Hospital, Estaing
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sébastien PERBET, Principal Investigator, University Hospital, Clermont-Ferrand
  • Overall Contact(s)
    • Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.