End stage renal disease Urological and Genital Diseases End stage renal disease
Conditions
Interventions
Two months run-in period: standard PD solution
After randomisation: ten months treatment with pH-neutral double-chambered PD solutions containing either lactate (one group) or bicarbonate (one group)
Sponsors
Fresenius Medical Care Deutschland GmbH (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 60 patients (European multicenter trial) 1. One month to 19 years 2. Continuous ambulatory peritoneal dialysis (CAPD) or continuous cycling peritoneal dialysis (CCPD) 3. Dwell volume 1100 ml/m^2 body surface area 4. Last peritonitis at least three weeks ago 5. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Reduced efficiency of peritoneal dialysis due to anatomic anomalies or intraperitoneal adhesions 2. Uncontrolled hyperphosphatemia 3. Severe pulmonary, cardiac, hepatic or systemic disease including any kind of malignancy 4. Current or recent (within 30 days) exposure to any investigational drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be the longitudinal change in 4h-D/P creatinine in the sequential PET examinations. Differential changes in this parameter will indicate differences in the development of the peritoneal solute transport status over time. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures will be surrogate parameters of mesothelial cell viability (CA-125), peritoneal neoangiogenesis (VEGF), fibrotic activity (TGF-beta) and local inflammation (Interleukin-6). With the same intention, the evolution of peritoneal histomorphology will be assessed in all patients available for sequential biopsies. Moreover, possible differential effects of lactate and bicarbonate buffer on the control of metabolic acidosis will be assessed by monthly blood gas analyses. Finally, the incidence and clinical course of peritonitis will be recorded as a possible indirect marker of local peritoneal macrophage function. | — |
Countries
Germany
Outcome results
None listed