Acute renale failure in intensive unit MedDRA version: 9.1 Level: LLT Classification code 10038436 Term: Renal failure acute
Conditions
Interventions
Trade Name: FLOLAN*EV FL 0,5MG+FL 50ML SOL
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Epoprostenol
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient with acute renal failure admitted to the Intensive Care Unit of our hospital requiring renal replacement therapy according to the latest international guidelines 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: H. they do not fulfil the inclusion criteria I. they are less than 18 years old J. they are pregnant women K. they have been treated with another experimental drug or device within 30 days before the admission to the present study L. they are positive to HIV infection M. they have been presenting an haemorrhage in the la test 24 hours N. they are thrombocytopenic (platelets count less than 30,000 cells/mm3)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to verify the feasibility and efficacy of prostacyclin versus heparin as antihemostatic agent during veno-venous hemodiafiltration (CVVHDF).;Secondary Objective: Monitoring effects of PROSTACYCLIJN on th platelets;Primary end point(s): nd | — |
Countries
Italy
Outcome results
None listed