Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy

NCT00264368 | Terminated Phase 4

• 1 other identifier: GCV-PRISMA
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Renal Failure; Cytomegalovirus Infections; Multi Organ Failure

Keywords

Renal replacement therapy; CMV disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Interventions

intravenous (IV) ganciclovir DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in need of continuous RRT and GCV treatment
• years of age or older.

You may not qualify if:

• Concomitant treatment with acyclovir or valacyclovir.
• Patient does not give informed consent.

Sponsors & Collaborators

• University of Oslo School of Pharmacy: lead

Study Sites (1)

Rikshospitalet, Section of Nephrology

Oslo, 0027, Norway

Location

MeSH Terms

Conditions

Acute Kidney Injury; Cytomegalovirus Infections; Multiple Organ Failure

Interventions

Ganciclovir

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Anders Åsberg, Ph.D.

  University of Oslo School of Pharmacy

  STUDY DIRECTOR

• Anders Hartmann, MD, Ph.D.

  Rikshospitalet, Medical Department

  PRINCIPAL INVESTIGATOR

• Jan F Bugge, MD, Ph.D.

  Rikshospitalet, Department of Anaesthesiology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 9, 2005
• First Posted: December 12, 2005
• Study Start: December 1, 2005
• Study Completion: June 1, 2007
• Last Updated: June 28, 2007

Record last verified: 2007-06

Locations

NO (1)