Peritoneal Dialysis (PD) is the preferred dialysis modality in children. Its major drawback is the limited technique survival due to infections and progressive ultrafiltration failure. Conventional PD solutions exert marked acute and chronic toxicity to local tissues. Prolonged exposure is associated with severe histopathological alterations including vasculopathy, neoangiogenesis, submesothelial fibrosis and a gradual loss of the mesothelial cell layer. Recently, more biocompatible PD solutions containing reduced amounts of toxic Glucose Degradation Products (GDPs) and buffered at neutral pH have been introduced into clinical practice. These solutions contain lactate, bicarbonate or a combination of both as buffer substance. Increasing evidence from clinical trials in adults and children suggests that the new PD fluids may allow for better long-term preservation of peritoneal morphology and function. However, the relative importance of the buffer in neutral-pH, low-GDP fluids is still unclear. In vitro, lactate is cytotoxic and vasoactive at the concentrations used in PD fluids. The BIOKID trial is designed to clarify the clinical significance of the buffer choice in biocompatible PD fluids.
Examinations: on clinical routine controls: blood tests, peritoneal equilibration tests, intraperitoneal pressure measurement.
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 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.
4. Current or recent (within 30 days) exposure to any investigational drug.
Nau B, Schmitt CP, Almeida M, Arbeiter K, Ardissino G, Bonzel KE, Edefonti A, Fischbach M, Haluany K, Misselwitz J, Kemper MJ, Rönnholm K, Wygoda S, Schaefer F, , BIOKID: randomized controlled trial comparing bicarbonate and lactate buffer in biocompatible peritoneal dialysis solutions in children [ISRCTN81137991]., BMC Nephrol, 2004, 5, 14, doi: 10.1186/1471-2369-5-14.