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SEVOKID: Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in ICU Patients With Acute Kidney Injury

Sponsor
University Hospital, Clermont-Ferrand (Other)
Overall Status
Unknown status
CT.gov ID
NCT02042599
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
26
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Describing a pharmacokinetic model of 48-h sevoflurane sedation in ICU patients with acute kidney failure

Condition or Disease Intervention/Treatment Phase
  • Drug: Sedation with sevoflurane during 48-hr in ICU
 Phase 2

Detailed Description

Prospective clinical monocentric study in ICU with sedated ventilated patients (presenting acute kidney failure) with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sevoflurane and its metabolites (hydroxyfluroisopropanol, fluoride)

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in ICU Patients With Acute Kidney Injury
Study Start Date :
Jan 1, 2014
Anticipated Primary Completion Date :
Feb 1, 2016
Anticipated Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: sevoflurane

Determination of plasmatic concentrations of sevoflurane at different times of a 48h sedation of sevoflurane in ICU patients with acute kidney injury

Drug: Sedation with sevoflurane during 48-hr in ICU
Other Names:
  • Determination of plasmatic concentrations of sevoflurane at different times of a 48h sedation of sevoflurane in ICU patients with acute kidney injury

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Determination of plasmatic concentrations of sevoflurane before using AnaConda® system [at 5min, 60 min, 24 hrs and just before the end of sedation.]

    Secondary Outcome Measures

    1. Determination of plasmatic concentrations of HFIP and fluoride [at 5min, 15 min, 60 min and just before the end of sedation. And 5 min, 10 min, 30 min, 120 min and 360 min after the end of sedation]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adult patients ventilated more than 48 h Stable respiratory and hemodynamic conditions Consent of patients or family Arterial line AKIN score = 3
    Exclusion Criteria:
    • BMI <30 Sevoflurane anaphylaxia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU de Clermont-Ferrand Clermont-Ferrand France 63003

    Sponsors and Collaborators

    • University Hospital, Clermont-Ferrand

    Investigators

    • Principal Investigator: Sébastien PERBET, University Hospital, Clermont-Ferrand

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Clermont-Ferrand
    ClinicalTrials.gov Identifier:
    NCT02042599
    Other Study ID Numbers:
    • CHU-0175
    • 2012-005746-37
    First Posted:
    Jan 23, 2014
    Last Update Posted:
    Jan 23, 2014
    Last Verified:
    Jan 1, 2014
    Keywords provided by University Hospital, Clermont-Ferrand
    Pharmacokinetics
    Sevoflurane
    Acute kidney injury
    Sedation
    ICU patients
    Additional relevant MeSH terms:
    Acute Kidney Injury
    Wounds and Injuries
    Sevoflurane

    Study Results

    No Results Posted as of Jan 23, 2014