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Dexmedetomidine Pharmacokinetics During Continuous Renal Replacement Therapy (CRRT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Helsinki University Central Hospital.
Recruitment status was  Recruiting
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

March 8, 2011
October 23, 2012
March 2011
March 2014   (final data collection date for primary outcome measure)
Dexmedetomidine clearance by continuous venovenous hemodialysis [ Time Frame: 10 hours from the start of the dexmedetomidine infusion ] [ Designated as safety issue: No ]
Dexmedetomidine clearance by continuous venovenous hemofiltration and hemodiafiltration [ Time Frame: 12 hours from the start of the dexmedetomidine infusion ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01314209 on ClinicalTrials.gov Archive Site
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Dexmedetomidine Pharmacokinetics During Continuous Renal Replacement Therapy (CRRT)
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.

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.

Interventional
Phase 2
Phase 3
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Kidney Injury
Drug: Dexmedetomidine
Dexmedetomidine 0.7 microg/kg/h 12-hour intravenous infusion
Experimental: dexmedetomidine
Intervention: Drug: Dexmedetomidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
Not Provided
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Kirsi-Maija Kaukonen, MD, PhD +358 50 4271059 maija.kaukonen@hus.fi
Contact: Suvi Vaara, MD +358 50 3312433 suvi.vaara@hus.fi
Finland
 
NCT01314209
11102010
No
Kirsi-Maija Kaukonen, Division of Anaesthesia and Intensive Care Medicine, Department of Surgery, Helsinki University Central Hospital
Helsinki University Central Hospital
Not Provided
Principal Investigator: Kirsi-Maija Kaukonen, MD, PhD Division of Anaesthesia and Intensive Care Medicine, Department of Surgery, HUCH
Helsinki University Central Hospital
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP