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

NCT ID: NCT02042599

Last Updated: 2014-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-03-31

Brief Summary

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

Detailed Description

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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)

Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sevoflurane

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

Group Type EXPERIMENTAL

Sedation with sevoflurane during 48-hr in ICU

Intervention Type DRUG

Interventions

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Sedation with sevoflurane during 48-hr in ICU

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sébastien PERBET

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

Central Contacts

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Patrick LACARIN

Role: CONTACT

04 73 75 11 95

Facility Contacts

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Patrick LACARIN

Role: primary

04 73 75 11 95

Other Identifiers

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2012-005746-37

Identifier Type: -

Identifier Source: secondary_id

CHU-0175

Identifier Type: -

Identifier Source: org_study_id

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