NCT00714857

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 3, 2014

Status Verified

January 1, 2014

Enrollment Period

3.2 years

First QC Date

July 7, 2008

Last Update Submit

January 2, 2014

Conditions

Pharmacokinetics

Keywords

ICU patientsDexmedetomidineSedationJudgedAttendingPhysician

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic parameters

    Blood samples are taken three times daily for characterizing the pharmacokinetic parameters

Study Arms (1)

1

EXPERIMENTAL

Patients receiving dexmedetomidine sedation

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

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.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • A previous history of intolerance to the study drug or related compounds and additives.
  • Existing significant haematological, endocrine, metabolic or gastrointestinal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, FIN-20521, Finland

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Timo T Iirola, M.D.

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 7, 2008

First Posted

July 14, 2008

Study Start

October 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 3, 2014

Record last verified: 2014-01

Locations

FI(1)