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

Arm | Intervention/treatment |
---|---|
sevoflurane | Drug: sevoflurane |
- 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.
- 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.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Contact: Patrick LACARIN | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
France | |
CHU de Clermont-Ferrand | Recruiting |
Clermont-Ferrand, France, 63003 | |
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr |
Principal Investigator: | Sébastien PERBET | University Hospital, Clermont-Ferrand |
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 |