Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Population Pharmacokinetics of Dexmedetomidine in ICU Patients (Dex-Pop-PK)

This study has been completed.
Information provided by (Responsible Party):
Timo Iirola, University of Turku Identifier:
First received: July 7, 2008
Last updated: January 2, 2014
Last verified: January 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 Intervention Phase
Drug: Dexmedetomidine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Population Pharmacokinetics of Dexmedetomidine in ICU Patients

Resource links provided by NLM:

Further study details as provided by University of Turku:

Primary Outcome Measures:
  • Pharmacokinetic parameters [ Time Frame: Blood samples are taken three times daily for characterizing the pharmacokinetic parameters ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: October 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients receiving dexmedetomidine sedation
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00714857

Turku University Hospital
Turku, Finland, FIN-20521
Sponsors and Collaborators
University of Turku
Principal Investigator: Timo T Iirola, M.D. Turku University Hospital
  More Information

No publications provided

Responsible Party: Timo Iirola, MD, University of Turku Identifier: NCT00714857     History of Changes
Other Study ID Numbers: Dex-Pop-PK
Study First Received: July 7, 2008
Last Updated: January 2, 2014
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by University of Turku:
ICU patients

Additional relevant MeSH terms:
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics, Non-Narcotic
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on November 20, 2014