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Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy

Primary Purpose

Acute Renal Failure, Cytomegalovirus Infections, Multi Organ Failure

Status
Terminated
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
intravenous (IV) ganciclovir
Sponsored by
University of Oslo School of Pharmacy
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Renal Failure focused on measuring Renal replacement therapy, CMV disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rikshospitalet, Section of Nephrology

Outcomes

Primary Outcome Measures

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 Outcome Measures

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

Full Information

First Posted
December 9, 2005
Last Updated
June 27, 2007
Sponsor
University of Oslo School of Pharmacy
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1. Study Identification

Unique Protocol Identification Number
NCT00264368
Brief Title
Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy
Official Title
Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Terminated
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Oslo School of Pharmacy

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Renal Failure, Cytomegalovirus Infections, Multi Organ Failure
Keywords
Renal replacement therapy, CMV disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
intravenous (IV) ganciclovir
Primary Outcome Measure Information:
Title
comparing the total clearance with the RRT derived clearance of GCV
Title
comparing the volume of distribution with historic controls of non Intensive Care Unit (ICU) patients
Secondary Outcome Measure Information:
Title
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.
Title
determine RRT derived GCV clearance during the different filtration/dialysis settings of the RRT machine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Åsberg, Ph.D.
Organizational Affiliation
University of Oslo School of Pharmacy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Anders Hartmann, MD, Ph.D.
Organizational Affiliation
Rikshospitalet, Medical Department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan F Bugge, MD, Ph.D.
Organizational Affiliation
Rikshospitalet, Department of Anaesthesiology
Official's Role
Study Chair
Facility Information:
Facility Name
Rikshospitalet, Section of Nephrology
City
Oslo
ZIP/Postal Code
0027
Country
Norway

12. IPD Sharing Statement

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Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy

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