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An evaluation of sodium removal with some peritoneal solutions a pilot study - ND

Conditions
end stage renal disease
MedDRA 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
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

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
NameTimeMethod
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
NameTimeMethod
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