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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Timo Iirola, University of Turku
ClinicalTrials.gov Identifier:
NCT00714857
First received: July 7, 2008
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

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
Pharmacokinetics
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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00714857

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

No publications provided

Responsible Party: Timo Iirola, MD, University of Turku
ClinicalTrials.gov 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
Dexmedetomidine
Sedation
Judged
Attending
Physician

Additional relevant MeSH terms:
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
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

ClinicalTrials.gov processed this record on April 16, 2014