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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00714857
Recruitment Status : Completed
First Posted : July 14, 2008
Last Update Posted : January 3, 2014
Information provided by (Responsible Party):
Timo Iirola, 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.

Condition or disease Intervention/treatment Phase
Pharmacokinetics Drug: Dexmedetomidine Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Pharmacokinetic parameters [ Time Frame: Blood samples are taken three times daily for characterizing the pharmacokinetic parameters ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00714857

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

Responsible Party: Timo Iirola, MD, University of Turku Identifier: NCT00714857     History of Changes
Other Study ID Numbers: Dex-Pop-PK
First Posted: July 14, 2008    Key Record Dates
Last Update Posted: January 3, 2014
Last Verified: January 2014

Keywords provided by Timo Iirola, University of Turku:
ICU patients

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action