An evaluation of sodium removal with some peritoneal solutions a pilot study - ND
- Conditions
- end stage renal diseaseMedDRA version: 8.1Level: LLTClassification code 10038444Term: Renal failure chronic
- Registration Number
- EUCTR2006-004618-42-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA PROVINCIALE DI LECCO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method