Cardiac Arrest Clinical Trial
— SEVOCAROfficial title:
SEVOflurane Inhalation in CARdiac Arrest Resuscitated Patients Treated With Therapeutic Hypothermia
Studying the feasibility of an initial sedation with inhalated sevoflurane during therapeutic hypothermia of cardiac arrests resuscitated patients.
Status | Recruiting |
Enrollment | 18 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | CHU de Clermont-Ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand | Hopital Gabriel Montpied, University Hospital, Estaing |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Determination of neurological prognostic of patients at ICU and hospital discharge | at day 1 | No | |
Secondary | Determination of systemic complications and organ failures during hospitalisation | at day 1 | No | |
Secondary | Evaluation of systemic inflammation and evolution with cytokines | at day 1 | No | |
Secondary | 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 | No |
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