Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Renal Failure Cytomegalovirus Infections Multi Organ Failure

Keywords

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Renal replacement therapy CMV disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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intravenous (IV) ganciclovir

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Anders Åsberg, Ph.D.

Role: STUDY_DIRECTOR

University of Oslo School of Pharmacy

Anders Hartmann, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Rikshospitalet, Medical Department

Jan F Bugge, MD, Ph.D.

Role: STUDY_CHAIR

Rikshospitalet, Department of Anaesthesiology

Locations

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Rikshospitalet, Section of Nephrology

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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GCV-PRISMA

Identifier Type: -

Identifier Source: org_study_id