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Optimising Peritoneal Dialysis: A Comparison of Adapted and Conventional Peritoneal Dialysis

A comparison of adapted and conventional peritoneal dialysis regimes in children treated with chronic peritoneal dialysis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000432617
Enrollment
19
Registered
2014-04-29
Start date
2014-03-17
Completion date
2014-06-30
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Title Optimising Peritoneal Dialysis: A Comparison of Adapted and Conventional Peritoneal Dialysis Objectives To investigate the effect of varying the dwell time and fill volume of peritoneal dialysis to determine whether a new dialysis regime (Adapted Peritoneal Dialysis) offers better fluid removal and solute clearance than conventional peritoneal dialysis in patients maintained on chronic peritoneal dialysis. Patient Impact Patients maintained on peritoneal dialysis are routinely seen in clinic with a blood test, clinical review and a review of their dialysis parameters and prescription every 2-4 weeks. Participation in this study will require a clinic review every 2 weeks. Therefore at most, participation will involve 3 extra visits with one extra blood test, usually taken via finger prick. For the majority of patients there will be no extra appointments required. The protocol for the study has been drawn up in consultation with dialysis-nurse co-ordinators and one parent whose child is on nightly peritoneal dialysis.

Interventions

Conventional Peritoneal Dialysis (Con-PD) Con-PD is delivered as a series of identical exchanges, each consisting of a fill, dwell and drain of an identical volume of dialysate. The volume of dialysate is determined as a maximum of either 40ml/kg or 1300ml/m2, depending on physician preference and patient comfort. The length of each cycle and the number of cycles are determined by the results of the annual Peritoneal Equilibration Test(PET) which defines patients as low, medium or high transport

Conventional Peritoneal Dialysis (Con-PD) Con-PD is delivered as a series of identical exchanges, each consisting of a fill, dwell and drain of an identical volume of dialysate. The volume of dialysate is determined as a maximum of either 40ml/kg or 1300ml/m2, depending on physician preference and patient comfort. The length of each cycle and the number of cycles are determined by the results of the annual Peritoneal Equilibration Test(PET) which defines patients as low, medium or high transporters. The overall length of the nightly dialysis programme is also determined by the lead nephrologist’s experience with the patient and what regime is most acceptable to the family in terms of solute clearance (measured by blood tests), fluid removal/ultrafiltration (determined by weight, clinical exam and blood pressure) and the impact that time on dialysis has on the child’s life (i.e. a baby will tolerate 12-14 hours on dialysis overnight whereas a teenager may be limited to 8-10 hours to facilitate school etc). Adapted PD (Ad-PD) Ad-PD is a new concept in PD and consists of several initial short, low volume cycles, followed by several long, higher volume cycles. In concept it is similar to how manual PD is frequently employed in intensive care, where there are more frequent changes made to cycle length and volume. Ad-PD uses the same machine, the same volume of fluid, and the same overall treatment time. As such there is no need for extra education of patients or parents. The trial will last 12 weeks with 6 weeks of Ad-PD and 6 weeks of Con-PD. The first week of the second treatment regime will be considered a wash-out period.

Sponsors

Department of Nephrology, The Royal Children's Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
12 Months to 19 Years
Healthy volunteers
No

Inclusion criteria

All patients aged >1 year who have been maintained on PD for > 3 months.

Exclusion criteria

Patients with a known impediment to higher volume exchanges such as previous abdominal wall problems or the presence of multiple adhesions will be excluded due to concerns with the larger volume fills. Patients with salt-losing nephropathies will be excluded as there is a concern that they may experience overly large fluid shifts with Ad-PD. The published study excluded those with an episode of peritonitis in the last 3 months, we will include these patients but will analyse their results separately.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026