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Completed

NCT Number: NCT02048683

A Pharmacokinetic Study of Sevoflurane Inhalation in Burn ICU Patients

Comparing a pharmacokinetic model of a short sevoflurane sedation in burn ICU patients with control ICU patients.

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Key information

Conditions

ICU Patients With Indication of Sedation Burns Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

Prospective clinical study in ICU with sedated ventilated patients with sevoflurane with the AnaConda® system, establishing pharmacokinetic model of sevoflurane and its metabolites (hydroxyfluroisopropanol, fluoride) comparing burn and non burn ICU patients

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients ventilated requiring invasive procedure in ICU
  • Stable respiratory and hemodynamic conditions
  • Consent of patients or family
  • Arterial line
  • Burn patients : burn area between 20 and 50% (3rd degree) OR non burn patients

Exclusion criteria

  • BMI <30
  • Sevoflurane anaphylaxia

Treatment and study plan

Short term sedation with sevoflurane in ICU

Drug

Primary outcomes

  1. Determination of plasmatic concentrations of sevoflurane

    Time frame: at 5min, 15 min, 60 min and just before the end of sedation.

Secondary outcomes

  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 5min, 10 min, 30 min, 60 min and 120 min after the end of sedation

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: SEVOBURN

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 29, 2014
Registry last updated
Oct 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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