Dexmedetomidine Pharmacokinetics During Continuous Renal Replacement Therapy (CRRT)

October 23, 2012 updated by: Helsinki University Central Hospital

Dexmedetomidine Pharmacokinetics During Continuous Venovenous Hemodialysis in Critically Ill Patients

The purpose of this study is to determine dexmedetomidine pharmacokinetics during continuous renal replacement therapy on critically ill patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Dexmedetomidine is a selective alpha-2-adrenergic agonist with sedative properties indicated for sedation of patients in the intensive care setting. ICU patients with acute kidney injury requiring renal replacement therapies frequently have changes in volume status causing alterations in drug pharmacokinetics. Although dexmedetomidine pharmacokinetics have been studied earlier on ICU patients, there is no information on its pharmacokinetics in critically ill patients needing continuous renal replacement therapy.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2
  • Phase 3

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
      • Helsinki, Finland, 00290
        • Recruiting
        • Meilahti Hospital, Division of Anaesthesia and Intensive Care Medicine, Department of Surgery, Helsinki University Central Hospital
        • Contact:
        • Contact:

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:

  • Age ≥ 18
  • Clinical need for sedation
  • Acute kidney injury requiring renal replacement therapy (according to ICUs standard operating procedures)

Exclusion Criteria:

  • Severe bradycardia (HR < 50/min)
  • AV conduction block II-III (unless pacemaker installed)
  • Severe hepatic impairment (bilirubin > 101 umol/l)
  • Pregnancy or lactation
  • Age < 18

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dexmedetomidine
Drug: Dexmedetomidine
Dexmedetomidine 0.7 microg/kg/h 12-hour intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dexmedetomidine clearance by continuous venovenous hemodialysis
Time Frame: 10 hours from the start of the dexmedetomidine infusion
10 hours from the start of the dexmedetomidine infusion

Collaborators and Investigators

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

Sponsor

Helsinki University Central Hospital

Investigators

  • Principal Investigator: Kirsi-Maija Kaukonen, MD, PhD, Division of Anaesthesia and Intensive Care Medicine, Department of Surgery, HUCH

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

March 1, 2011

Primary Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

March 8, 2011

First Submitted That Met QC Criteria

March 11, 2011

First Posted (Estimate)

March 14, 2011

Study Record Updates

Last Update Posted (Estimate)

October 24, 2012

Last Update Submitted That Met QC Criteria

October 23, 2012

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11102010

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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