end stage renal disease MedDRA version: 8.1 Level: LLT Classification code 10038444 Term: Renal failure chronic
Conditions
Interventions
Pharmaceutical Form: Solution for peritoneal dialysis
Current Sponsor code: physioneal 1.36
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 62-
Pharmaceutical Form: Solu
Sponsors
AZIENDA OSPEDALIERA PROVINCIALE DI LECCO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: adults patients up to 18 year in peritoneal dialitic treatment with the same methodic CAPD and APD with at least 3 months of treatment at the moment of inclusion Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: presence of one of these condition Woman in fertile age that dont use valid contraceptive methods,pregnancy, woman in breast-feeding,malignant neoplasia without remission signs,an episody of peritonitis into the 4 weeks before the inclusion in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate how solutions for peritoneal dyalisys in commerce remove much more sodium than the other in a single peritoneal exchenge every day;Secondary Objective: evaluation of natriemia;Primary end point(s): Much more remove of peritoneal sodium with one of the solutions use in the study | — |
Countries
Italy
Outcome results
None listed