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Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU (DEX PK)

This study has been completed.
Information provided by:
Orion Corporation, Orion Pharma Identifier:
First received: September 4, 2008
Last updated: April 20, 2009
Last verified: April 2009
The study will examine dexmedetomidine levels in the blood of critically ill intensive care patients to understand how it is broken down by the body.

Condition Intervention Phase
Pharmacokinetics Sedation Drug: Dexmedetomidine Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pharmacokinetics of Intravenous Dexmedetomidine for Prolonged Infusion in Critically Ill, Ventilated Patients in Intensive Care Unit; an Open, Non-Randomised, Single Centre Study

Resource links provided by NLM:

Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:
  • Pharmacokinetic variables. [ Time Frame: From start of treatment to 48 hr follow-up. ]

Enrollment: 13
Study Start Date: September 2008
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: Dexmedetomidine
2 ml ampoule containing 200 micrograms dexmedetomidine for dilution with 48 ml 0/9% sodium chloride injection. Titrated to efficacy.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Written informed consent obtained from the patient's legal representative according to local regulations before starting any study procedures other than pre-screening
  • Patients sedated and ventilated in ICU for whom sedation is expected to be clinically required for at least 24 hours, as determined by the responsible physician
  • Prescribed light to moderate sedation (target RASS = 0 to -3)

Exclusion Criteria:

  • Acute severe intracranial or spinal neurological disorder due to vascular causes, infection, intracranial expansion or injury
  • Uncompensated acute circulatory failure at screening (severe hypotension with mean arterial pressure(MAP) < 55 mmHg despite vasopressor and inotrope therapy)
  • Heart rate (HR) < 50 beats/min for longer than 5 min between screening and starting study treatment
  • Atrioventricular (AV)-conduction block II-III (unless pacemaker installed)
  • Severe hepatic impairment (e.g. bilirubin > 101 μmol/L)
  • Need for continuous muscle relaxation
  • Any condition which would significantly interfere with the collection of study data
  • Burn injuries or other conditions requiring regular anesthesia or surgery
  • Use of centrally acting alpha-2 agonists or antagonists within 24 hours prior to starting the study (e.g. dexmedetomidine, clonidine, tizanidine, apraclonidine and brimonidine)
  • Known allergy to dexmedetomidine or any excipients of the study treatment
  • Patients who have or are expected to have treatment withdrawn or withheld due to poor prognosis
  • Patients receiving sedation for therapeutic indications rather than to tolerate the ventilator (e.g. epilepsy)
  • Patients unlikely to require continuous sedation during mechanical ventilation (e.g. Guillain-Barré syndrome)
  • Patients who are unlikely to be weaned from mechanical ventilation; e.g. diseases/injuries primarily affecting the neuromuscular function of the respiratory apparatus such as clearly irreversible disease requiring prolonged ventilatory support (e.g. high spinal cord injury or advanced amyotrophic lateral sclerosis)
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Please refer to this study by its identifier: NCT00747721

Turku University Hospital
Turku, Finland
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Principal Investigator: Timo Iirola Turku University Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Andrew Wighton, Orion Corporation, Orion Pharma Identifier: NCT00747721     History of Changes
Other Study ID Numbers: 3005016
EUDRACT: 2008-001646-10
Study First Received: September 4, 2008
Last Updated: April 20, 2009

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 processed this record on August 23, 2017