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

This study has been completed.
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT00747721
First received: September 4, 2008
Last updated: April 20, 2009
Last verified: April 2009
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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. ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided by Orion Corporation, Orion Pharma

Additional 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
Study First Received: September 4, 2008
Last Updated: April 20, 2009
Health Authority: Finland: Finnish Medicines Agency

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 July 22, 2014