Population Pharmacokinetics of Dexmedetomidine in ICU Patients (Dex-Pop-PK)
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|ClinicalTrials.gov Identifier: NCT00714857|
Recruitment Status : Completed
First Posted : July 14, 2008
Last Update Posted : January 3, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Pharmacokinetics||Drug: Dexmedetomidine||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Population Pharmacokinetics of Dexmedetomidine in ICU Patients|
|Study Start Date :||October 2007|
|Primary Completion Date :||December 2010|
|Study Completion Date :||December 2010|
Patients receiving dexmedetomidine sedation
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.
- Pharmacokinetic parameters [ Time Frame: Blood samples are taken three times daily for characterizing the pharmacokinetic parameters ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00714857
|Turku University Hospital|
|Turku, Finland, FIN-20521|
|Principal Investigator:||Timo T Iirola, M.D.||Turku University Hospital|