Pharmacokinetic of Sevoflurane During a 48h Sedation in I... | NCT01196754

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

NCT01196754

Sponsor

University Hospital, Clermont-Ferrand

Status

Completed

Last Update Posted

Sep 8, 2010Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Sedation

Interventions

sevoflurane

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Apr 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Jul 15, 2010

First Submission Date that Met QC Criteria

Sep 7, 2010

First Posted Date

Sep 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2010

Last Update Posted Date

Sep 8, 2010Estimated

Name	Class
University Hospital, Estaing	OTHER

Description Module

Brief 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.

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Label	Type	Description	Intervention Names
sevoflurane	Other		Other: sevoflurane

Name	Type	Description	Arm Group Labels	Other Names
sevoflurane	Other		sevoflurane

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determination of plasmatic concentrations of sévoflurane at different times of a 48h sedation of sévoflurane.		during 48 hours

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel Bourdeaux	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Clermont-Ferrand		Clermont-Ferrand		63003	France

Intervention Browse Module

MeSH Terms

ID	Term
D000077149	Sevoflurane

Ancestor Terms

ID	Term
D008738	Methyl Ethers
D004987	Ethers
D009930	Organic Chemicals
D006845	Hydrocarbons, Fluorinated

Browse Leaves

Not provided

Browse Branches

Not provided