SEVOflurane Inhalation in CARdiac Arrest Resuscitated Patients Treated With Therapeutic Hypothermia (SEVOCAR)

July 28, 2016 updated by: University Hospital, Clermont-Ferrand
Studying the feasibility of an initial sedation with inhalated sevoflurane during therapeutic hypothermia of cardiac arrests resuscitated patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • CHU de Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: sevoflurane
Drug: sevoflurane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of neurological prognostic of patients at ICU and hospital discharge
Time Frame: at day 1
at day 1
Determination of systemic complications and organ failures during hospitalisation
Time Frame: at day 1
at day 1
Evaluation of systemic inflammation and evolution with cytokines
Time Frame: at day 1
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.
at day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

University Hospital, Estaing
Hopital Gabriel Montpied

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

July 16, 2014

First Submitted That Met QC Criteria

July 24, 2014

First Posted (Estimate)

July 25, 2014

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0199
  • 2014-001196-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Arrest

Clinical Trials on sevoflurane

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe