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Population Pharmacokinetics of Dexmedetomidine in ICU Patients

Phase 2
Completed
Conditions
Pharmacokinetics
Interventions
Registration Number
NCT00714857
Lead Sponsor
University of Turku
Brief Summary

Dexmedetomidine is a new, highly selective and potent alpha2-adrenoreceptor agonist registered for sedation of patients in intensive care units. Although the pharmacokinetics of dexmedetomidine have been studied previously also in an ICU setting, there is no information on the pharmacokinetics of long-lasting (\>48 hours) dexmedetomidine infusions in humans.

The aim of this study is to study the pharmacokinetics of long-lasting dexmedetomidine infusions in ICU patients using the population pharmacokinetics approach.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
21
Inclusion Criteria
  • Age ≥ 18 years.
  • Need for dexmedetomidine sedation (determined by the responsible physician).
  • Predicted length of dexmedetomidine sedation ≥ 48 hours.
  • Written informed consent from the patient or the relatives of the participating patient.
Exclusion Criteria
  • A previous history of intolerance to the study drug or related compounds and additives.
  • Existing significant haematological, endocrine, metabolic or gastrointestinal disease

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
1DexmedetomidinePatients receiving dexmedetomidine sedation
Primary Outcome Measures
NameTimeMethod
Pharmacokinetic parametersBlood samples are taken three times daily for characterizing the pharmacokinetic parameters
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Turku University Hospital

🇫🇮

Turku, Finland

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