End stage renal failure
Conditions
Interventions
Product Name: Physioneal PD solutions
Pharmaceutical Form: Solution for peritoneal dialysis
INN or Proposed INN: glucose
Concentration unit: % (W/V) percent weight/volume
Concentration type: range
Con
Sponsors
Barts and The London NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All incident patients selected to use a PD system that has physiological and standard solutions available. 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: - Patients unable to provide informed consent - Patients where the use of a certain solution is indicated or contra-indicated for medical reasons (e.g. known allergy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the outcome of peritoneal dialysis when "standard" or "biocompatible" solutions are used. Primary end-point is: peritonitis rate. ;Secondary Objective: Secondary Endpoints: · Patients using physiological solutions will have better preservation of residual kidney function. · Patients using physiological solutions will have smaller changes in peritoneal membrane function assessed by PET than control · Patients using physiological solutions will have reduced composite end-point of mortality and PD failure defined by transfer to HD · Patients using physiological solutions will have better quality of life assessed by SF-36 ;Primary end point(s): Primary aim is to compare peritonitis. However, some patients may have more than 1 episode | — |
Countries
United Kingdom
Outcome results
None listed