Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
ICU, University Hospital Estaing, CHU Clermont-Fd, France
Pharmacy, University Hospital Clermont-Fd, France
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01196754
First received: July 15, 2010
Last updated: September 7, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Sedation
Other: sevoflurane

Study Type: Interventional
Study Design: Primary Purpose: Screening
Official Title: Pharmacokinetic of Sevoflurane During a 48h Sedation in ICU With AnaConDa®

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Determination of plasmatic concentrations of sévoflurane at different times of a 48h sedation of sévoflurane. [ Time Frame: during 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determination of plasmatic concentrations of HFIP and fluoride at different times of a 48h sedation of sévoflurane. Determination of a pharmacokinetic model of sévoflurane. [ Time Frame: during 48 hours ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: March 2008
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
sevoflurane Other: sevoflurane

Detailed 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01196754

Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
ICU, University Hospital Estaing, CHU Clermont-Fd, France
Pharmacy, University Hospital Clermont-Fd, France
Investigators
Principal Investigator: Daniel Bourdeaux University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: Patrick LACARIN, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01196754     History of Changes
Other Study ID Numbers: CHU-0079
Study First Received: July 15, 2010
Last Updated: September 7, 2010
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Pharmacokinetics
Sevoflurane
Fluorides
Sedation
Adult patients with a predicted sedation more than 48 h
Stable respiratory and hemodynamic conditions for SBT
Consent of patients
Arterial line

Additional relevant MeSH terms:
Sevoflurane
Anesthetics
Anesthetics, General
Anesthetics, Inhalation
Central Nervous System Agents
Central Nervous System Depressants
Hematologic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014