A Pharmacokinetic Study of Sevoflurane Inhalation in Burn ICU Patients (SEVOBURN)

October 23, 2015 updated by: University Hospital, Clermont-Ferrand
Comparing a pharmacokinetic model of a short sevoflurane sedation in burn ICU patients with control ICU patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prospective clinical study in ICU with sedated ventilated patients with sevoflurane with the AnaConda® system, establishing pharmacokinetic model of sevoflurane and its metabolites (hydroxyfluroisopropanol, fluoride) comparing burn and non burn ICU patients

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Chu Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients ventilated requiring invasive procedure in ICU

    • Stable respiratory and hemodynamic conditions
    • Consent of patients or family
    • Arterial line
    • Burn patients : burn area between 20 and 50% (3rd degree) OR non burn patients

Exclusion Criteria:

  • BMI <30

    • Sevoflurane anaphylaxia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: burn ICU patients
Determination of plasmatic concentrations of sevoflurane at different times of a short term sedation of sevoflurane in burn versus non burn ICU patients
Drug: Short term sedation with sevoflurane in ICU
OTHER: non burn ICU patients
Determination of plasmatic concentrations of sevoflurane at different times of a short term sedation of sevoflurane in burn versus non burn ICU patients
Drug: Short term sedation with sevoflurane in ICU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determination of plasmatic concentrations of sevoflurane
Time Frame: at 5min, 15 min, 60 min and just before the end of sedation.
at 5min, 15 min, 60 min and just before the end of sedation.

Secondary Outcome Measures

Outcome Measure
Time Frame
Determination of plasmatic concentrations of HFIP and fluoride
Time Frame: at 5min, 15 min, 60 min and just before the end of sedation. And 5min, 10 min, 30 min, 60 min and 120 min after the end of sedation
at 5min, 15 min, 60 min and just before the end of sedation. And 5min, 10 min, 30 min, 60 min and 120 min after the end of sedation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

January 13, 2014

First Submitted That Met QC Criteria

January 28, 2014

First Posted (ESTIMATE)

January 29, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

October 26, 2015

Last Update Submitted That Met QC Criteria

October 23, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0174
  • 2013-000960-26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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