Population Pharmacokinetics of Dexmedetomidine in ICU Patients

Pharmacokinetics Clinical Trial

— Dex-Pop-PK  

Official title:

Population Pharmacokinetics of Dexmedetomidine in ICU Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00714857
• Other study ID #: Dex-Pop-PK
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 7, 2008
• Last updated: January 2, 2014
• Start date: October 2007
• Est. completion date: December 2010

Study information

• Verified date: January 2014
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• Dexmedetomidine
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.

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameters		Blood samples are taken three times daily for characterizing the pharmacokinetic parameters	No