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

April 20, 2009 updated by: Orion Corporation, Orion Pharma

Pharmacokinetics of Intravenous Dexmedetomidine for Prolonged Infusion in Critically Ill, Ventilated Patients in Intensive Care Unit; an Open, Non-Randomised, Single Centre Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland
        • Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic variables.
Time Frame: From start of treatment to 48 hr follow-up.
From start of treatment to 48 hr follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orion Corporation, Orion Pharma

Investigators

  • Principal Investigator: Timo Iirola, Turku University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

September 4, 2008

First Submitted That Met QC Criteria

September 4, 2008

First Posted (Estimate)

September 5, 2008

Study Record Updates

Last Update Posted (Estimate)

April 21, 2009

Last Update Submitted That Met QC Criteria

April 20, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3005016
  • EUDRACT: 2008-001646-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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