Is it possible to increase free sodium removal by the use of low sodium peritoneal dialysis solution? - Delta

Conditions: Subjects with renal failure treated with peritoneal dialysis

Registration Number: EUCTR2004-002041-12-GB

Lead Sponsor: Gambro Lundia AB, Corporate Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Chronic renal failure.
Stable subjects treated in a CAPD program using a minimum of 3 bags per day or in a APD program using at least one daytime exchange with 3-6 hours dwell time.
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

Low blood pressure (office sitting SBP = 110 mmHg and/or symptomatic orthostatic hypotension).
Natremia < 103 mmol/l, after two consecutive measurements.
Peritonitis within one month prior to 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 investigate if it is possible to increase 24-hour free sodium removal in peritoneal dialysis patients treated with low sodium peritoneal dialysis solutions.;Secondary Objective: Improved blood pressure control assessed by, a) ambulatory blood pressure measurement, b) office blood pressure. <br>Fluid status as determined by, Weight, Total body water (predicted by bio-impedance spectroscopy and measured by deuterium dilution).<br>Differences in thirst. <br>Safety for the patient using low sodium peritoneal dialysis solutions assessed by, hypotension requiring clinical intervention, hyponatremia < 125 mM, and urine volume;Primary end point(s): To assess free sodium removal increase during 24 hour in PD patients treated with a low sodium product compared to the situation on conventional fluids.

Secondary Outcome Measures