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

Primary Purpose

Cardiac Arrest, Therapeutic Hypothermia

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sevoflurane
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Cardiac arrest, Therapeutic hypothermia, Sevoflurane, Sedation, Patient resuscitated from cardiac arrest, Requiring sedation, Adult patients, Patient covered by french health care system

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

sevoflurane

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 16, 2014
Last Updated
July 28, 2016
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
University Hospital, Estaing, Hopital Gabriel Montpied
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1. Study Identification

Unique Protocol Identification Number
NCT02201134
Brief Title
SEVOflurane Inhalation in CARdiac Arrest Resuscitated Patients Treated With Therapeutic Hypothermia
Acronym
SEVOCAR
Official Title
SEVOflurane Inhalation in CARdiac Arrest Resuscitated Patients Treated With Therapeutic Hypothermia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
University Hospital, Estaing, Hopital Gabriel Montpied

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Therapeutic Hypothermia
Keywords
Cardiac arrest, Therapeutic hypothermia, Sevoflurane, Sedation, Patient resuscitated from cardiac arrest, Requiring sedation, Adult patients, Patient covered by french health care system

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sevoflurane
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
sevoflurane
Primary Outcome Measure Information:
Title
Determination of the feasibility of a sedation with inhalated sevoflurane in cardiac arrest resuscitated patients
Description
The feasibility is evaluated by the number of side effects due to treatment until discharge from hospital.
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
Determination of neurological prognostic of patients at ICU and hospital discharge
Time Frame
at day 1
Title
Determination of systemic complications and organ failures during hospitalisation
Time Frame
at day 1
Title
Evaluation of systemic inflammation and evolution with cytokines
Time Frame
at day 1
Title
Evaluation of markers specific of brain ischemia (S100 protein and neuron-specific enolase)
Description
at 3 times: before starting sevoflurane sedation, 24 hours, 48 hours and 72 hours after starting sevoflurane sedation.
Time Frame
at day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien PERBET
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr

12. IPD Sharing Statement

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SEVOflurane Inhalation in CARdiac Arrest Resuscitated Patients Treated With Therapeutic Hypothermia

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