The Clinical Effects of Korean Adapted APD in Automated Peritoneal Dialysis Patients
Condition: Renal Insufficiency, Chronic
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to assess the impact of "adapted" Automated Peritoneal Dialysis(APD)
      sequentially prescribed shorter and longer dwell exchanges with smaller and larger fill
      volumes in comparison with "conventional APD" prescribed a standard continuous cycling
      peritoneal dialysis on the efficacy of dialysis.
    

Detailed description: 
      It is well known that the efficiency of peritoneal dialysis (PD) varies with the duration of
      the dwell and the prescribed fill volume. Short dwell ensures adequate UF because the osmotic
      gradient is maintained while prolonged dwell allows for more solute clearance because the
      dialysate-to-plasma ratio (D/P) for uremic toxins such as creatinine and phosphate enhances.
      In terms of intraperitoneal fill volume, large fill volume improves the removal of uremic
      toxins for two reasons: a larger volume can be drained and therefore the clearance achieved
      is greater, and the peritoneal surface area available for the exchange is increased.
      Conversely, small fill volume promotes the process of UF because of the potentially low
      intraperitoneal pressure (IPP). Overall, choosing the optimal dwell time and exchange volume
      should promote UF and increase the removal of uremic toxins-urea in particular-to the
      dialysate.

      Thus, this study proposes a new way of giving PD, using a modified version of conventional
      prescription which firstly uses 2 cycles of short dwell time with a small fill volume to
      promote UF and subsequently uses 2 cycles of longer dwell time and a larger fill volume to
      promote removal of uremic toxins from the blood.

      Although it was already evaluated the efficiency of this modified prescription by Fischbach
      et al, the prescription currently prescribed in most Korean hospitals shows some differences
      in dwell time, fill volume and exchange cycling. The aim of this study is to assess the
      clinical effect of "Korean Adapted APD" (KAPD-A) compared to "Korean Conventional APD"
      (KAPD-C).

      This is a multicenter, randomized, open-label, parallel controlled study. Patients who meet
      inclusion criteria will be randomized into each group at the ratio of 1:1. For incident
      patients, after being stable on APD and peritonitis-free at least 4 weeks, which is called as
      "run-in period", group 1 will start with 8 weeks of KAPD-C treatment and then cross over to 8
      weeks of treatment with KAPD-A while group 2 will be performed on the contrary from KAPD-A to
      KAPD-C treatment.

      Each patient will receive the same total amount of dialysate (8000 mL), given over the same
      8-hour duration. First at the inclusion visit called "as baseline", and then visits will take
      place every 4 weeks for a total of 16 weeks.
    

Intervention name(s): KAPD-C; KAPD-A
Intervention type(s): Procedure; Procedure
Intervention description(s): KAPD-C is a treatment prescribed 2000 mL fill volume per each 4 cycles of dialysis session with an exchange cycle of 90 minutes.; KAPD-A is a treatment initially prescribed 1500 mL fill volume per each 2 cycles of dialysis session with an exchange cycle of 45 minutes and followed by 2 cycles of 2500 mL fill volume with an exchange cycle of 135 minutes.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adapted APD; dwell time; fill volume