Dexmedetomidine Pharmacokinetics During Continuous Renal Replacement Therapy (CRRT)

Acute Kidney Injury Clinical Trial

Official title:

Dexmedetomidine Pharmacokinetics During Continuous Venovenous Hemodialysis in Critically Ill Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01314209
• Other study ID #: 11102010
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: March 8, 2011
• Last updated: October 23, 2012
• Start date: March 2011

Study information

• Verified date: March 2011
• Source: Helsinki University Central Hospital
• Contact: Kirsi-Maija Kaukonen, MD, PhD
• Phone: +358 50 4271059
• Email: maija.kaukonen[@]hus.fi
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine 0.7 microg/kg/h 12-hour intravenous infusion

Locations

Country	Name	City	State
Finland	Meilahti Hospital, Division of Anaesthesia and Intensive Care Medicine, Department of Surgery, Helsinki University Central Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dexmedetomidine clearance by continuous venovenous hemodialysis		10 hours from the start of the dexmedetomidine infusion	No