Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy

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.

Study Overview

• Status: Terminated
• Conditions: Acute Renal Failure; Cytomegalovirus Infections; Multi Organ Failure
• Intervention / Treatment: Drug: intravenous (IV) ganciclovir

• Study Type: Interventional
• Enrollment (Anticipated): 6
• Phase: Phase 4

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0027
    • Rikshospitalet, Section of Nephrology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

• Sponsor: University of Oslo School of Pharmacy
• Investigators: Study Director: Anders Åsberg, Ph.D., University of Oslo School of Pharmacy; Principal Investigator: Anders Hartmann, MD, Ph.D., Rikshospitalet, Medical Department; Study Chair: Jan F Bugge, MD, Ph.D., Rikshospitalet, Department of Anaesthesiology

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: December 9, 2005
• First Submitted That Met QC Criteria: December 9, 2005
• First Posted (Estimate): December 12, 2005

Study Record Updates

• Last Update Posted (Estimate): June 28, 2007
• Last Update Submitted That Met QC Criteria: June 27, 2007
• Last Verified: June 1, 2007

More Information

Terms related to this study

• Keywords: Renal replacement therapy; CMV disease
• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Infections; Kidney Diseases; Urologic Diseases; Renal Insufficiency; DNA Virus Infections; Shock; Herpesviridae Infections; Acute Kidney Injury; Cytomegalovirus Infections; Multiple Organ Failure; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Ganciclovir; Ganciclovir triphosphate
• Other Study ID Numbers: GCV-PRISMA