SEVOflurane Inhalation in CARdiac Arrest Resuscitated Patients Treated With Therapeutic Hypothermia

Cardiac Arrest Clinical Trial

— SEVOCAR  

Official title:

SEVOflurane Inhalation in CARdiac Arrest Resuscitated Patients Treated With Therapeutic Hypothermia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02201134
• Other study ID #: CHU-0199
• Secondary ID: 2014-001196-31
• Status: Recruiting
• Phase: N/A
• First received: July 16, 2014
• Last updated: July 28, 2016
• Start date: July 2014
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Hypothermia
• Therapeutic Hypothermia

Intervention

Drug:
• sevoflurane

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Hopital Gabriel Montpied, University Hospital, Estaing

Country where clinical trial is conducted

France, 

Outcome

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