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

Phase 2UnknownNCT02042599

University Hospital, Clermont-Ferrand12 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Kidney Injury

Interventions

Sedation with sevoflurane during 48-hr in ICUDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Outcomes

Primary Outcomes

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 Outcomes

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

Central Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95 placarin@chu-clermontferrand.fr

Data from ClinicalTrials.gov

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