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

Primary Purpose

ICU Patients With Indication of Sedation

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Short term sedation with sevoflurane in ICU
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ICU Patients With Indication of Sedation focused on measuring Pharmacokinetics, Sevoflurane, Burn, Sedation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

burn ICU patients

non burn ICU patients

Arm Description

Determination of plasmatic concentrations of sevoflurane at different times of a short term sedation of sevoflurane in burn versus 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

Outcomes

Primary Outcome Measures

Determination of plasmatic concentrations of sevoflurane

Secondary Outcome Measures

Determination of plasmatic concentrations of HFIP and fluoride

Full Information

First Posted
January 13, 2014
Last Updated
October 23, 2015
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT02048683
Brief Title
A Pharmacokinetic Study of Sevoflurane Inhalation in Burn ICU Patients
Acronym
SEVOBURN
Official Title
A Pharmacokinetic Study of Sevoflurane Inhalation in Burn ICU Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

Brief Summary
Comparing a pharmacokinetic model of a short sevoflurane sedation in burn ICU patients with control ICU patients.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ICU Patients With Indication of Sedation
Keywords
Pharmacokinetics, Sevoflurane, Burn, Sedation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
burn ICU patients
Arm Type
Experimental
Arm Description
Determination of plasmatic concentrations of sevoflurane at different times of a short term sedation of sevoflurane in burn versus non burn ICU patients
Arm Title
non burn ICU patients
Arm Type
Other
Arm Description
Determination of plasmatic concentrations of sevoflurane at different times of a short term sedation of sevoflurane in burn versus non burn ICU patients
Intervention Type
Drug
Intervention Name(s)
Short term sedation with sevoflurane in ICU
Primary Outcome Measure Information:
Title
Determination of plasmatic concentrations of sevoflurane
Time Frame
at 5min, 15 min, 60 min and just before the end of sedation.
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien PERBET
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
29455032
Citation
Perbet S, Bourdeaux D, Lenoire A, Biboulet C, Pereira B, Sadoune M, Plaud B, Launay JM, Bazin JE, Sautou V, Mebazaa A, Houze P, Constantin JM, Legrand M; PRONOBURN group. Sevoflurane for procedural sedation in critically ill patients: A pharmacokinetic comparative study between burn and non-burn patients. Anaesth Crit Care Pain Med. 2018 Dec;37(6):551-556. doi: 10.1016/j.accpm.2018.02.001. Epub 2018 Feb 15.
Results Reference
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A Pharmacokinetic Study of Sevoflurane Inhalation in Burn ICU Patients

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