Anticoagulation with Prostaglandin E1 and unfractioned Heparin versus Placebo and unfractioned Heparin during continuous venovenous hemofiltratio

Conditions: Male and female patients with acute renal failure and treated with continuous venovenous hemofiltration therapy

Registration Number: EUCTR2005-003211-69-AT

Lead Sponsor: Medical University of Vienna

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures