Male and female patients with acute renal failure and treated with continuous venovenous hemofiltration therapy
Conditions
Interventions
Trade Name: Alprostapint 500µg Konzentrat zur Infusionsbereitung
Product Name: Alprostapint 500 µg Konzentrat zur Infusionsbereitung
Pharmaceutical Form: Concentrate for solution for infusion
Pharmace
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female and male intensive care patients aged 18-80 years Diagnosis of acute renal failure Treatment with continuous venovenous hemofilartion therapy Adequate contraception in women withh ildbearing potential signed informed consent 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: Pregnant and nursing women known incompatibility against substances used in this trial pre-existing clotting or platelet disorder Concomitant therapy with Aspirin within two weeks before study start or during the study Concomitant tretament with nonsteroidal anti-inflammatory drugs (NSAIDs) within two weeks before the study start or during the study Concomitant therapy with Marcoumar within two weeks before study start or during the study Concomitant therapy with other extracorporeal replacement therapies Patients simultaneously participating, or having participated in the last month, in another clinical trial Patients taken in custody by court or authorities Patients already treated under this protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstarte superior efficacy of anticoagulation therapy with regard to the duration of the hemofilter life-span using the combined regime of Prostaglandin E1 and Heparin in comparison to a combined regime of Placebo and Heparin;Secondary Objective: Toassess safety and tolerability of the combined regime of Prostaglandin E1 and Heparin and of the combined regime of Placebo and Heparin;Primary end point(s): The time (hours and minutes) till the first change of the hemofilter used in the extracorporeal hemofiltration | — |
Countries
Austria
Outcome results
None listed