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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


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
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