Cytomegalovirus Infections Clinical Trial
Official title:
Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy
Verified date | June 2007 |
Source | University of Oslo School of Pharmacy |
Contact | n/a |
Is FDA regulated | No |
Health authority | Norway: Norwegian Medicines Agency |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 6 |
Est. completion date | June 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Norway | Rikshospitalet, Section of Nephrology | Oslo |
Lead Sponsor | Collaborator |
---|---|
University of Oslo School of Pharmacy |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | comparing the total clearance with the RRT derived clearance of GCV | |||
Primary | comparing the volume of distribution with historic controls of non Intensive Care Unit (ICU) patients | |||
Secondary | 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. | |||
Secondary | determine RRT derived GCV clearance during the different filtration/dialysis settings of the RRT machine |
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