Proof of Concept of Adapted PD in Children (PC-AAPD)
Condition: Primary Study Outcome: Sodium Clearance in Dialysis; Solute Removal; Ultrafiltration
Study type: Interventional

Summary: 
      The purpose of this study is to validate the concept of adapted automated PD a modified
      Peritoneal Equilibration Test (PET), will be performed in children on chronic PD. Instead of
      a single 4 hour standard dwell, two double mini PET using the same type and total volume of
      dialysate and the same total dwell time (150min) will be performed in randomised sequence. An
      double mini test consists of two identical dwells, reflecting routine PD, the other one of a
      short small dwell followed by a long, large dwell as suggested from adapted PD regimes
      successfully applied in adult PD patients.
    

Detailed description: 
      Present peritoneal dialysis treatment is hampered by the limited efficacy of currently
      applied regimen, mainly consisting of a series of standard dwells with the same amount of
      dialysate and dwell time. New cycler machines available for routine therapy now allow
      modification of time and volume of each dwell and thus to individually adapt PD regime. In
      fact a recent multi-center trial in adult patients suggests that a PD regimen consisting of a
      sequence of short small dwells followed by large and long lasting dwells in total applying
      the same amount of dialysate during the same total treatment time substantially improves
      fluid and toxin removal. Underlying beneficial mechanisms are highly debated. Prior to
      adaptation of such PD treatment patterns to children on automated PD in the routine clinical
      setting, the tolerability and biochemical effects need to be demonstrated.

      To this end, the Peritoneal Equilibration Test (PET), which is routinely performed in
      children during a day hospital treatment to analyse peritoneal transport function, will be
      modified. Instead of a single 4 hour standard dwell, two double mini PET using the same type
      and total volume of dialysate and the same total dwell time (150min) will be performed in
      randomised sequence in a total of 15 stable pediatric PD patients treated in four different
      European pediatric dialysis centres. The conventional double mini PET consists of two
      identical cycles (fill volume 1 L/m², 75 min), the adapted one of a short, small cycle (0.6
      mL/m² BSA, 30 min) followed by a long, large cycle (1.4 mL/m², 120 min). A total of 22 ml of
      blood will be drawn via a peripheral i.v. line, intraperitoneal pressure, in clinical routine
      controlled once during a PET, will be measured with each dwell.

      The study analyses the time and volume dependent PD transport mechanisms. Patients included
      may benefit from the detailed analysis of peritoneal membrane function, allowing for
      optimisation of the individual PD prescription.
    

Intervention name(s): Adapted double mini PET; Standard double mini PET
Intervention type(s): Other; Other
Intervention description(s): The modified double mini PET mimics the treatment of adapted PD and thus allows its validation; The standard double mini PET reflects the routine PD treatment in children and is used for standardized comparison
Other intervention name(s): Peritoneal Equilibration Test (PET); Peritoneal dialysis; Peritoneal Equilibration Test (PET); Peritoneal dialysis
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adapted APD; Dialytic Sodium Removal; Ultrafiltration; Clearance rate; Intraperitoneal pressure