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.
|Acute Renal Failure Cytomegalovirus Infections Multi Organ Failure||Drug: intravenous (IV) ganciclovir||Phase 4|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy|
- 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
- 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
|Study Start Date:||December 2005|
|Study Completion Date:||June 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00264368
|Rikshospitalet, Section of Nephrology|
|Oslo, Norway, 0027|
|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|