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

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ClinicalTrials.gov Identifier: NCT02201134
Recruitment Status : Recruiting
First Posted : July 25, 2014
Last Update Posted : July 29, 2016
Sponsor:
Collaborators:
University Hospital, Estaing
Hopital Gabriel Montpied
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
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Brief Summary:
Studying the feasibility of an initial sedation with inhalated sevoflurane during therapeutic hypothermia of cardiac arrests resuscitated patients.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Therapeutic Hypothermia Drug: sevoflurane Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SEVOflurane Inhalation in CARdiac Arrest Resuscitated Patients Treated With Therapeutic Hypothermia
Study Start Date : July 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
sevoflurane Drug: sevoflurane


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Determination of neurological prognostic of patients at ICU and hospital discharge [ Time Frame: at day 1 ]
  2. Determination of systemic complications and organ failures during hospitalisation [ Time Frame: at day 1 ]
  3. Evaluation of systemic inflammation and evolution with cytokines [ Time Frame: at day 1 ]
  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02201134


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
University Hospital, Estaing
Hopital Gabriel Montpied
Investigators
Principal Investigator: Sébastien PERBET University Hospital, Clermont-Ferrand
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02201134     History of Changes
Other Study ID Numbers: CHU-0199
2014-001196-31
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016

Keywords provided by University Hospital, Clermont-Ferrand:
Cardiac arrest
Therapeutic hypothermia
Sevoflurane
Sedation
 Patient resuscitated from cardiac arrest
Requiring sedation
Adult patients
Patient covered by french health care system

Additional relevant MeSH terms:
Hypothermia
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms
Sevoflurane
 Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs