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Trial registered on ANZCTR


Registration number
ACTRN12614000432617
Ethics application status
Approved
Date submitted
23/03/2014
Date registered
29/04/2014
Date last updated
29/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Optimising Peritoneal Dialysis:
A Comparison of Adapted and Conventional Peritoneal Dialysis
Scientific title
A comparison of adapted and conventional peritoneal dialysis regimes in children treated with chronic peritoneal dialysis
Secondary ID [1] 284313 0
Nil
Universal Trial Number (UTN)
U1111-1154-8402
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 291463 0
Condition category
Condition code
Renal and Urogenital 291832 291832 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 289035 0
Treatment: Devices
Comparator / control treatment
Each participant will act as their own control.
The control/comparator treatment is conventional peritoneal dialysis.
This is a parallel cross over trial. Patients will be randomised into 2 groups, to start with either 6 weeks of Con-PD (Group A) or with 6 weeks of Ad-PD (Group B). They will then cross-over to a further 6 weeks of Ad-PD (Group A) or Con-PD (Group B). The dialysate used during the study will be the same in both treatment arms.
Control group
Active

Outcomes
Primary outcome [1] 291750 0
Primary outcome measure is ultrafiltration(UF) volume/kg. This is the net volume of fluid removed during the dialysis program divided by the participant’s weight. The nightly UF volume is recorded on the individual removable card inserted into each dialysis machine and is downloaded routinely at the patient’s clinic appointment by the PD nurse co-ordinators.
Timepoint [1] 291750 0
This will be assessed at each 2-weekly study visit for a total of 12 weeks.
Secondary outcome [1] 307409 0
Secondary outcome measure is clearance of urea.
Timepoint [1] 307409 0
This will be calculated from the blood, urine and dialysate samples taken in the 2-weekly clinic visit for a total of 12 weeks.
Secondary outcome [2] 307577 0
Secondary outcome measure is the metabolic cost of clearance as measured by glucose absorption.
Timepoint [2] 307577 0
This will be calculated from the blood, urine and dialysate samples taken in the 2-weekly clinic visit for a total of 12 weeks.

Eligibility
Key inclusion criteria
All patients aged >1 year who have been maintained on PD for > 3 months.
Minimum age
12 Months
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation Procedures
Patients will be randomised to Group A or B by sequentially numbered opaque sealed envelopes, simple randomisation using coin-tossing.
Blinding Arrangements
This study will not be blinded as it would be impossible to blind parents to the delivered therapy since the programme is clearly displayed on the front screen of the dialysis machine. It would also be unsafe to blind the clinicians and nurse co-ordinators to the new PD regime as it may result in a changed UF and thus necessitate changes to the regime.
Patients will be randomised to Group A or B by sequentially numbered opaque sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised to Group A or B by sequentially numbered opaque sealed envelopes, simple randomisation using coin-tossing.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
STATISTICAL METHODS
Sample size estimation
Discussion with Susan Donath from the Clinical Epidemiology and Biostatistics Unit has confirmed that there is insufficient data in the published paper to calculate a sample size for this study. However, since the published paper had 19 patients in the trial, we feel that it is reasonable to recruit a similar number in RCH and attempt to repeat the study.
Population to be analysed
All patients in RCH treated with PD by the nephrology team who do not meet the exclusion criteria.
Statistical Analysis Plan
Statistical analysis will be performed using GraphPad Prism version 6.00 for Windows, GraphPad Software, La Jolla California USA. Differences between the two dialysis regimes will be evaluated using the paired-samples t-test. Values of p less than 0.05 will be considered statistically significant. The first week in each regime will be considered a wash-out period.
Interim Analyses
There is no plan for interim analysis of the data. All data will be analysed at the end of the study.

REFERENCE
Perit Dial Int. 2011 Jul-Aug;31(4):450-8. doi: 10.3747/pdi.2010.00146. Epub 2011 Mar 31.
The beneficial influence on the effectiveness of automated peritoneal dialysis of varying the dwell time (short/long) and fill volume (small/large): a randomized controlled trial.
Fischbach M1, Issad B, Dubois V, Taamma R.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/03/2014
Actual
17/03/2014
Date of last participant enrolment
Anticipated
30/06/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
19
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2227 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 7907 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 288989 0
Self funded/Unfunded
Name [1] 288989 0
Unfunded
Country [1] 288989 0
Primary sponsor type
Hospital
Name
Department of Nephrology, The Royal Children's Hospital
Address
50 Flemington Road
Parkville
VIC 3052
Country
Australia
Secondary sponsor category [1] 287633 0
None
Name [1] 287633 0
Address [1] 287633 0
Country [1] 287633 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290764 0
The Royal Children's Hospital
Ethics committee address [1] 290764 0
50 Flemington Road
Parkville
Victoria 3052
Ethics committee country [1] 290764 0
Australia
Date submitted for ethics approval [1] 290764 0
Approval date [1] 290764 0
24/01/2014
Ethics approval number [1] 290764 0
HREC 33237A

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47170 0
Dr Cathy Quinlan
Address 47170 0
Nephrology Department
The Royal Children's Hospital
50 Flemington Road
Parkville
Victoria 3052
Country 47170 0
Australia
Phone 47170 0
+61 3 93455054
Fax 47170 0
Email 47170 0
[email protected]
Contact person for public queries
Name 47171 0
Cathy Quinlan
Address 47171 0
Nephrology Department
The Royal Children's Hospital
50 Flemington Road
Parkville
Victoria 3052
Country 47171 0
Australia
Phone 47171 0
+61 3 93455054
Fax 47171 0
Email 47171 0
[email protected]
Contact person for scientific queries
Name 47172 0
Cathy Quinlan
Address 47172 0
Nephrology Department
The Royal Children's Hospital
50 Flemington Road
Parkville
Victoria 3052
Country 47172 0
Australia
Phone 47172 0
+61 3 93455054
Fax 47172 0
Email 47172 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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