Population Pharmacokinetics of Dexmedetomidine in ICU Patients

University of Turku21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Pharmacokinetics

Interventions

DexmedetomidineDRUG

The patients are given a normal loading dose (10 min infusion at a rate of 3-6 μg/kg/h) of dexmedetomidine followed by continuous infusion of 0.1 - 2.5 μg/kg/h for the period of time the responsible physician finds reasonable.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Turku University Hospital

Turku, Finland

Outcomes

Primary Outcomes

Pharmacokinetic parameters

Time frame: Blood samples are taken three times daily for characterizing the pharmacokinetic parameters

Data from ClinicalTrials.gov

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