Medical Intensive Care Unit Renal failure Renal Replacement Therapy MedDRA version: 9.1 Level: LLT Classification code 10038435 Term: Renal failure MedDRA version: 9.1 Level: HLT Classification code 10011827 Term: Cytomegaloviral infections
Conditions
Interventions
Trade Name: Cymevene
Pharmaceutical Form: Intravenous infusion
Sponsors
Medizinische Universität Wien, Univ. Klinik für Innere Medizin III, Abteilung für Gastroenterologie
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. Other extracorporeal therapy than CVVHDF. 2. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Austria
Outcome results
None listed