Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Renal Failure Cytomegalovirus Infections Multi Organ Failure |
Drug: intravenous (IV) ganciclovir |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy |
- 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
- 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
| Estimated Enrollment: | 6 |
| Study Start Date: | December 2005 |
| Study Completion Date: | June 2007 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Norway | |
| Rikshospitalet, Section of Nephrology | |
| Oslo, Norway, 0027 | |
| Study Director: | Anders Åsberg, Ph.D. | University of Oslo School of Pharmacy |
| Principal Investigator: | Anders Hartmann, MD, Ph.D. | Rikshospitalet, Medical Department |
| Study Chair: | Jan F Bugge, MD, Ph.D. | Rikshospitalet, Department of Anaesthesiology |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00264368 History of Changes |
| Other Study ID Numbers: | GCV-PRISMA |
| Study First Received: | December 9, 2005 |
| Last Updated: | June 27, 2007 |
| Health Authority: | Norway: Norwegian Medicines Agency |
Keywords provided by University of Oslo School of Pharmacy:
|
Renal replacement therapy CMV disease |
Additional relevant MeSH terms:
|
Cytomegalovirus Infections Acute Kidney Injury Multiple Organ Failure Renal Insufficiency Herpesviridae Infections DNA Virus Infections Virus Diseases Kidney Diseases |
Urologic Diseases Shock Pathologic Processes Ganciclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013