Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy

Phase 4

Terminated

• Conditions: Acute Renal Failure; Cytomegalovirus Infections; Multi Organ Failure

• Registration Number: NCT00264368
• Lead Sponsor: University of Oslo School of Pharmacy

Brief Summary

In order to optimize anti-cytomegalovirus (CMV) treatment with ganciclovir (GCV), in patients with multi organ failure treated with continuous renal replacement therapy (RRT), more information about ganciclovir pharmacokinetics in this setting is needed.

The primary objective is to describe the pharmacokinetics of ganciclovir in critically ill patients with acute renal failure treated with continuous renal replacement therapy, with a special emphasis on the extra-renal clearance and distribution volume.

Secondary objectives are to investigate if any co-factors, such as serum creatinine, weight, general hydration status, rest function of the native kidneys, etc. can help to describe the pharmacokinetics of GCV in these patients on continuous RRT as well as the relative influence of filtrations and dialysis on GCV elimination during different modalities of the treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2005-12-09
• Study First Submitted QC: 2005-12-09
• Study First Posted: 2005-12-12
• Status Verified: 2007-06
• Study Completion: 2007-06
• Last Update Submitted: 2007-06-27
• Last Update Posted: 2007-06-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Patients in need of continuous RRT and GCV treatment
• 18 years of age or older.

Exclusion Criteria

• Concomitant treatment with acyclovir or valacyclovir.
• Patient does not give informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
comparing the total clearance with the RRT derived clearance of GCV
comparing the volume of distribution with historic controls of non Intensive Care Unit (ICU) patients

Secondary Outcome Measures

Name	Time	Method
comparing GCV plasma concentration and population model derived estimates of these concentrations when including different relevant clinical co-factors such as: weight, S-creatinine, CL-creatinine, hydration, albumin, rest function of native kidneys etc.
determine RRT derived GCV clearance during the different filtration/dialysis settings of the RRT machine

Trial Locations

Locations (1)

Rikshospitalet, Section of Nephrology; 🇳🇴 Oslo, Norway