Administration of pH-Neutral Peritoneal Dialysis Solutions Containing Lactate or Bicarbonate in Children
Condition: Chronic Renal Failure; Peritoneal Membrane Disorder
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      For details please see Nau B, Schmitt CP et al; BMC Nephrol. 2004 Oct 14;5:14.
    

Intervention name(s): lactate and bicarbonate buffered dialysis solutions
Intervention type(s): Drug
Intervention description(s): Either PD-solution will be applied. Number of cycles and glucose concentration will be varied according to clinical needs. Sleep Safe system will be used and connected to Sleep Safe Cyclers in patient on CCPD.
Other intervention name(s): BicaVera; Balance
Intervention MeSH terms: Dialysis Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: peritoneal dialysis; bicarbonate/lactate buffer; peritoneal transport capacity; ultrafiltration; children