PHARMACOKINETICS OF GANCICLOVIR DURING CONTINUOUS RENAL REPLACEMENT THERAPY

Conditions: Medical Intensive Care UnitRenal failureRenal Replacement Therapy
MedDRA version: 9.1Level: LLTClassification code 10038435Term: Renal failure
MedDRA version: 9.1Level: HLTClassification code 10011827Term: Cytomegaloviral infections

Registration Number: EUCTR2007-002069-11-AT

Lead Sponsor: Medizinische Universität Wien, Univ. Klinik für Innere Medizin III, Abteilung für Gastroenterologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Age 18 to 70 years.
2. Suspected or proven cytomegalovirus infection requiring parenteral antiviral therapy.
3. Continuous venovenous hemodiafiltration (CVVHDF) or Continuous venovenous hemofiltration (CVVHF) due to acute renal failure

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Other extracorporeal therapy than CVVHDF.
2.Pregnancy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The study is conducted to investigate the pharmacokinetics of ganciclovir during contuous renal replacement therapy in critically ill patients with proven or suspected cytomegalovirus infection.;Secondary Objective: ;Primary end point(s): The following pharmacokinetic parameters will be determined: maximum and minimum plasma concentration (cmax, cmin), area under the concentration curve (AUC), total clearance (Cltot), hemodiafiltration clearance (ClCVVHDF), hemofiltration clearance (ClCVVHF), volume of distribution (Vd), half-life (t½ ) and the elimination fraction.

Secondary Outcome Measures