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Dexmedetomidine Pharmacokinetics During Continuous Renal Replacement Therapy (CRRT)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Helsinki University Central Hospital.
Recruitment status was:  Recruiting
Information provided by:
Helsinki University Central Hospital Identifier:
First received: March 8, 2011
Last updated: October 23, 2012
Last verified: March 2011
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: 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:

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 ]

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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 identifier: NCT01314209

Contact: Kirsi-Maija Kaukonen, MD, PhD +358 50 4271059
Contact: Suvi Vaara, MD +358 50 3312433

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   
Contact: Suvi Vaara, MD    +358 503312433   
Sponsors and Collaborators
Helsinki University Central Hospital
Principal Investigator: Kirsi-Maija Kaukonen, MD, PhD Division of Anaesthesia and Intensive Care Medicine, Department of Surgery, HUCH
  More Information

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

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

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
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 processed this record on May 25, 2017