None listed
Conditions
Brief summary
Peritoneal dialysis (PD) removes toxins that rise during kidney failure. Historically, we looked at removal of small water-soluble molecules as a surrogate marker of dialysis effectiveness. However, given its poor relationship with patient outcomes, recent guidelines have moved away from these targets and is now focusing on patient reported outcomes. Moreover, protein-bound uraemic toxins (PBUT), which are poorly removed in dialysis, may have more of a role in patient outcomes. Additionally, studies in haemodialysis and chronic kidney disease have shown that high-fibre diet may help reduce the generation of these PBUTs but studies are lacking in the PD population. We will determine effects of PBUT removal on patient outcomes (quality of life measure using EQ-5D-5L, symptoms and mood score using IPOS-renal and an assessment of physical function including hand-grip strength and timed chair-to-stand test) and preservation of residual kidney function. We will also look at the effects of increased fibre intake on PBUT levels and above-mentioned patient outcomes in a group of PD patients. We hypothesise that a high fibre diet will reduce PBUT generation in the PD population. We hypothesise that this reduction in PBUT levels will correlate with better patient outcomes and preservation of residual kidney function.
Interventions
This is a randomised controlled study using a parallel group design where incident PD patients (those who have started PD in the 3 months prior to the study) will be recruited. Patients will be randomised into two groups: those receiving dianeal (n=30), and those on dianeal receiving a high fibre diet (n=30).
The dianeal with high fibre group/ Intervention arm : This group of participants will receive dianeal PD solutions (dianeal by Baxter) with dextrose concentrations of 0.55%, 1.5%, 2.5% a
This is a randomised controlled study using a parallel group design where incident PD patients (those who have started PD in the 3 months prior to the study) will be recruited. Patients will be randomised into two groups: those receiving dianeal (n=30), and those on dianeal receiving a high fibre diet (n=30). The dianeal with high fibre group/ Intervention arm : This group of participants will receive dianeal PD solutions (dianeal by Baxter) with dextrose concentrations of 0.55%, 1.5%, 2.5% and 4.25%. They will receive these solutions according to their clinical need without a strict prescription (so a minimum prescription of 2L exchange for 4 hours per day to a maximum of 16L per day) for 12 months. Each participant in the intervention group will self-administer these solutions as part of their PD dialysis routine. In addition, they will have a fibre supplement with resistant starch in the form of wheat dextrin (Benefiber). They will start with 1 sachet (1 sachet= 3g) per day for 1 week before increasing the dose by 1 sachet per week over 4 weeks until any of the following targets have been reached; maximum recommended Benefiber dose of 4 sachets daily (12g/day), recommended daily fibre intake of 25g/day or the participants’ maximum tolerated amount. The participants will be on this treatment for 12 months or their maximum tolerated time. The monitoring and adherence of fibre intake will be monitored with phone interviews and a fibre diary by researchers via phone calls and/or face-to-face appointments every 8 weeks. Dianeal (Baxter) PD fluid contains glucose, sodium chloride, sodium lactate, magnesium chloride hexahydrate and calcium chloride dihydrate All the interventions will be delivered by the study team with minimum 5 years of experience with conducting a trial. Information and delivery will be mostly by face-to-face consultations but also via telehealth in some circumstances at the study locations (Eastern Health and Monash Health) Measurements of uraemic toxins (water soluble, middle-molecule and protein-bound uraemic toxins), renal parameters (measured kidney function, urine output) and patient focused outcomes (patient health related quality of life measure using EQ-5D-5L questionnaire, patient’s symptom and mood score using IPOS-renal questionnaire and an assessment of physical function using hand grip strength and timed chair-to-stand test) will be measured.
Sponsors
Eastern Health Clinical School
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age greater than or equal to 18 Incident Peritoneal Dialysis (PD) patients (Patient who have been newly started on PD in the last 3 months)
Exclusion criteria
Patients who are currently pregnant Patients with Cognitive Impairment or learning differences that are unable to consent Patient with active malignancy
Outcome results
None listed