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NCT01196754 Clinical Trial

Pharmacokinetic of Sevoflurane During a 48h Sedation in Intensive Care Unit With AnaConDa®

Sedation Clinical Trial

— Anaconda  

Official title:
Pharmacokinetic of Sevoflurane During a 48h Sedation in ICU With AnaConDa®

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01196754
Other study ID # CHU-0079
Secondary ID
Status Completed
Phase N/A
First received July 15, 2010
Last updated September 7, 2010
Start date March 2008
Est. completion date May 2009

Study information
Verified date September 2010
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial Summary

This is a prospective clinical monocentric study in ICU with sedated ventilated patients with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sevoflurane.

Description:

Prospective clinical monocentric study in ICU with sedated ventilated patients with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sévoflurane and its metabolites (hydroxyfluroisopropanol, fluoride)

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date May 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients ventilated more than 48 h

- Stable respiratory and hemodynamic conditions

- Consent of patients or family

- Arterial line

Exclusion Criteria:

- Acute kidney injury

- Obesity

- Sevoflurane anaphylaxia

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Other:
• sevoflurane

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

Sponsors (3)
Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand Pharmacy, University Hospital Clermont-Fd, France, University Hospital, Estaing

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Determination of plasmatic concentrations of sévoflurane at different times of a 48h sedation of sévoflurane. during 48 hours Yes
Secondary Determination of plasmatic concentrations of HFIP and fluoride at different times of a 48h sedation of sévoflurane. Determination of a pharmacokinetic model of sévoflurane. during 48 hours Yes
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