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
About this trial
This is an interventional treatment trial for Acute Renal Failure focused on measuring Renal replacement therapy, CMV disease
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.
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
NCT ID
NCT00264368
First Posted
December 9, 2005
Last Updated
June 27, 2007
Sponsor
University of Oslo School of Pharmacy
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
Learn more about this trial
Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy
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