Acute Renal Failure, Cytomegalovirus Infections, Multi Organ Failure
Conditions
Keywords
Renal replacement therapy, CMV disease
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.
Interventions
DRUGintravenous (IV) ganciclovir
Sponsors
University of Oslo School of Pharmacy
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Norway
Outcome results
None listed