Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy

Cytomegalovirus Infections Clinical Trial

Official title:

Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00264368
• Other study ID #: GCV-PRISMA
• Status: Terminated
• Phase: Phase 4
• First received: December 9, 2005
• Last updated: June 27, 2007
• Start date: December 2005
• Est. completion date: June 2007

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 2007
• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Cytomegalovirus Infections
• Multi Organ Failure
• Multiple Organ Failure

Intervention

Drug:
• intravenous (IV) ganciclovir

Locations

Country	Name	City	State
Norway	Rikshospitalet, Section of Nephrology	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo School of Pharmacy

Country where clinical trial is conducted

Norway, 

Outcome

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