NCT01196754

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 8, 2010

Completed
Last Updated

September 8, 2010

Status Verified

September 1, 2010

Enrollment Period

1.1 years

First QC Date

July 15, 2010

Last Update Submit

September 7, 2010

Conditions

Sedation

Keywords

PharmacokineticsSevofluraneFluoridesSedationAdult patients with a predicted sedation more than 48 hStable respiratory and hemodynamic conditions for SBTConsent of patientsArterial line

Outcome Measures

Primary Outcomes (1)

  • Determination of plasmatic concentrations of sévoflurane at different times of a 48h sedation of sévoflurane.

    during 48 hours

Secondary Outcomes (1)

  • 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

Study Arms (1)

sevoflurane

OTHER
Other: sevoflurane

Interventions

sevofluraneOTHER
sevoflurane

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients ventilated more than 48 h
  • Stable respiratory and hemodynamic conditions
  • Consent of patients or family
  • Arterial line

You may not qualify if:

  • Acute kidney injury
  • Obesity
  • Sevoflurane anaphylaxia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Interventions

Sevoflurane

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Daniel Bourdeaux

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
SCREENING
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 15, 2010

First Posted

September 8, 2010

Study Start

March 1, 2008

Primary Completion

April 1, 2009

Study Completion

May 1, 2009

Last Updated

September 8, 2010

Record last verified: 2010-09

Locations

FR(1)