Back to resultsPharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in ICU Patients With Acute Kidney Injury (SEVOKID)
Primary Purpose
Acute Kidney Injury
Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Sedation with sevoflurane during 48-hr in ICU
Sponsored by
About this trial
This is an interventional treatment trial for Acute Kidney Injury focused on measuring Pharmacokinetics, Sevoflurane, Acute kidney injury, Sedation, ICU patients
Eligibility Criteria
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
Sites / Locations
- CHU de Clermont-Ferrand
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
sevoflurane
Arm Description
Determination of plasmatic concentrations of sevoflurane at different times of a 48h sedation of sevoflurane in ICU patients with acute kidney injury
Outcomes
Primary Outcome Measures
Determination of plasmatic concentrations of sevoflurane before using AnaConda® system
Secondary Outcome Measures
Determination of plasmatic concentrations of HFIP and fluoride
Full Information
NCT ID
NCT02042599
First Posted
January 14, 2014
Last Updated
January 22, 2014
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT02042599
Brief Title
Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in ICU Patients With Acute Kidney Injury
Acronym
SEVOKID
Official Title
Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in ICU Patients With Acute Kidney Injury
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
5. Study Description
Brief Summary
Describing a pharmacokinetic model of 48-h sevoflurane sedation in ICU patients with acute kidney failure
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
Pharmacokinetics, Sevoflurane, Acute kidney injury, Sedation, ICU patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sevoflurane
Arm Type
Experimental
Arm Description
Determination of plasmatic concentrations of sevoflurane at different times of a 48h sedation of sevoflurane in ICU patients with acute kidney injury
Intervention Type
Drug
Intervention Name(s)
Sedation with sevoflurane during 48-hr in ICU
Other Intervention Name(s)
Determination of plasmatic concentrations of sevoflurane at different times of a 48h sedation of sevoflurane in ICU patients with acute kidney injury
Primary Outcome Measure Information:
Title
Determination of plasmatic concentrations of sevoflurane before using AnaConda® system
Time Frame
at 5min, 60 min, 24 hrs 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 5 min, 10 min, 30 min, 120 min and 360 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
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 de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Daniel BOURDEAUX
First Name & Middle Initial & Last Name & Degree
Jean-Etienne BAZIN
First Name & Middle Initial & Last Name & Degree
Jean-Michel CONSTANTIN
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in ICU Patients With Acute Kidney Injury
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