Administration of pH-Neutral Peritoneal Dialysis Solutions Containing Lactate or Bicarbonate in Children
Status:
Completed
Trial end date:
2007-03-01
Target enrollment:
Participant gender:
Summary
Peritoneal Dialysis (PD) is the preferred treatment modality in children with end-stage renal
disease. Unfortunately progressive alterations of the peritoneal membrane occur with time on
PD, leading to a continuous loss of peritoneal transport function. Recently, double-chambered
PD solutions with less Glucose Degradation Products (GDPs) and neutral pH have been approved
for the European market. Short term administration suggests comparable clearance rates
compared with conventional solutions. In vitro studies demonstrate an improved local immune
defense system. To compensate for metabolic acidosis, the available solutions either contain
lactate or bicarbonate, the impact of either buffer on long term acidosis control and
peritoneal membrane integrity, however, is unknown.
The prospective, European multi-center study will provide the first long term administration
of pH neutral, low GDP solutions in children. 60 children will randomly be treated with a
bicarbonate (BicaVera) and a lactate based solution (Balance), respectively. The primary end
point will be the effect of either PD-solution on peritoneal transport characteristics (D/P
Creatinine). Secondary end-points will be the effects on ultrafiltration capacity, acid-base
balance, peritoneal morphology, incidence and severity of peritonitis, and on surrogate
parameters of biocompatibility and carbonyl stress. Moreover, potential genetic determinants
of the peritoneal transporter status and of the continued morphological transformation of the
peritoneum will be assessed.
After a 2 month run-in period, using a conventional, acidic, single-chambered PD-solution,
the patients will be randomized to a 10 month study period using BicaVera and Balance,
respectively. Dialysis regime and follow up in the out-patient clinic will be performed
according to clinical needs (every 4 weeks); episodes of peritonitis will be treated
according to international guidelines. Bicarbonate supplements will be prescribed at a dose
of 0.5 mmol/kg *d, if blood bicarbonate levels fall below 17 mmol/l. PD adequacy will be
verified by routine, monthly venous blood sampling and a capillary blood gas analysis. 2-5 ml
of blood will be drawn for analysis of relevant gene polymorphisms. At study entry, after 3,
6 and 10 months, a 24h dialysate- and urine collection, a peritoneal equilibration test an
intraperitoneal pressure measurement will be performed. Peritoneal biopsies will be obtained
at any time of abdominal surgery. Adverse events will be screened meticulously. The trial
will be carried out in accordance with the German medicines act (AMG) and other local
requirements, with particular reference to the ICH guidelines for Good Clinical Practice, and
the declaration of Helsinki. At study end, the patients will decide together with the
responsible physician which PD-fluid should be used further one.