Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in ICU Patients With Acute Kidney Injury
Phase 2
- Conditions
- Acute Kidney Injury
- Interventions
- Drug: Sedation with sevoflurane during 48-hr in ICU
- Registration Number
- NCT02042599
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- 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)
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 12
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description sevoflurane Sedation with sevoflurane during 48-hr in ICU 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
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
CHU de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France