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Dexmedetomidine Pharmacokinetics During Continuous Renal Replacement Therapy (CRRT)

This study is currently recruiting participants.
Verified March 2011 by Helsinki University Central Hospital
Sponsor:
Information provided by:
Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01314209
First received: March 8, 2011
Last updated: October 23, 2012
Last verified: March 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Acute Kidney Injury
 Drug: Dexmedetomidine
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dexmedetomidine Pharmacokinetics During Continuous Venovenous Hemodialysis in Critically Ill Patients

Resource links provided by NLM:

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Dexmedetomidine clearance by continuous venovenous hemodialysis [ Time Frame: 10 hours from the start of the dexmedetomidine infusion ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: March 2011
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dexmedetomidine Drug: Dexmedetomidine
Dexmedetomidine 0.7 microg/kg/h 12-hour intravenous infusion

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314209

Contacts
Contact: Kirsi-Maija Kaukonen, MD, PhD +358 50 4271059 maija.kaukonen@hus.fi
Contact: Suvi Vaara, MD +358 50 3312433 suvi.vaara@hus.fi

Locations
Finland
Meilahti Hospital, Division of Anaesthesia and Intensive Care Medicine, Department of Surgery, Helsinki University Central Hospital Recruiting
Helsinki, Finland, 00290
Contact: Kirsi-Maija Kaukonen, MD, PhD     +358 504271059     maija.kaukonen@hus.fi    
Contact: Suvi Vaara, MD     +358 503312433     suvi.vaara@hus.fi    
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Principal Investigator: Kirsi-Maija Kaukonen, MD, PhD Division of Anaesthesia and Intensive Care Medicine, Department of Surgery, HUCH
  More Information

No publications provided

Responsible Party: Kirsi-Maija Kaukonen, Division of Anaesthesia and Intensive Care Medicine, Department of Surgery, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01314209     History of Changes
Other Study ID Numbers: 11102010
Study First Received: March 8, 2011
Last Updated: October 23, 2012
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Helsinki University Central Hospital:
dexmedetomidine
pharmacokinetics
critical illness
continuous renal replacement therapy

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
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 May 16, 2013