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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00747721
First Posted: September 5, 2008
Last Update Posted: April 21, 2009
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.
Information provided by:
Orion Corporation, Orion Pharma
  Purpose
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
Dexmedetomidine
Drug: Dexmedetomidine
2 ml ampoule containing 200 micrograms dexmedetomidine for dilution with 48 ml 0/9% sodium chloride injection. Titrated to efficacy.

  Eligibility

Information from the National Library of Medicine

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

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)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00747721


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrew Wighton, Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT00747721     History of Changes
Other Study ID Numbers: 3005016
EUDRACT: 2008-001646-10
First Submitted: September 4, 2008
First Posted: September 5, 2008
Last Update Posted: April 21, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
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