SEVOflurane Inhalation in CARdiac Arrest Resuscitated Patients Treated With Therapeutic Hypothermia

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

Detailed Description
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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.

Official Title
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SEVOflurane Inhalation in CARdiac Arrest Resuscitated Patients Treated With Therapeutic Hypothermia

Conditions
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Cardiac Arrest, Therapeutic Hypothermia

Intervention / Treatment
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* Drug: sevoflurane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: sevoflurane<br> | Drug: sevoflurane<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at day 1 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac arrest, Therapeutic hypothermia, Sevoflurane, Sedation, Patient resuscitated from cardiac arrest, Requiring sedation, Adult patients, Patient covered by french health care system