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Trial record 4 of 658 for:    Sevoflurane

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

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ClinicalTrials.gov Identifier: NCT02042599
Recruitment Status : Unknown
Verified January 2014 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Not yet recruiting
First Posted : January 23, 2014
Last Update Posted : January 23, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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

Condition or disease Intervention/treatment Phase
Acute Kidney Injury 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)

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2014
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane

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




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02042599


Contacts
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Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
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France
CHU de Clermont-Ferrand Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sub-Investigator: Daniel BOURDEAUX         
Sub-Investigator: Jean-Etienne BAZIN         
Sub-Investigator: Jean-Michel CONSTANTIN         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Sébastien PERBET University Hospital, Clermont-Ferrand

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02042599     History of Changes
Other Study ID Numbers: CHU-0175
2012-005746-37
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: January 23, 2014
Last Verified: January 2014

Keywords provided by University Hospital, Clermont-Ferrand:
Pharmacokinetics
Sevoflurane
Acute kidney injury
Sedation
ICU patients

Additional relevant MeSH terms:
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Sevoflurane
Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs