Subjects with renal failure treated with peritoneal dialysis
Conditions
Interventions
Product Name: Deltasol L
Pharmaceutical Form: Solution for peritoneal dialysis
INN or Proposed INN: Glucose
CAS Number: 50-99-7
Concentration unit: mmol/l millimole(s)/litre
Concentration type: equal
Sponsors
Gambro Lundia AB, Corporate Research
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Fluid status as determined by, Weight, Total body water (predicted by bio-impedance spectroscopy and measured by deuterium dilution). Differences in thirst. 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. | — |
Countries
Sweden, United Kingdom
Outcome results
None listed