RecruitingACTRN12623000531617

Determining the utility of uraemic toxins in peritoneal dialysis to optimise patient care

Determining the utility of uraemic toxins in peritoneal dialysis to optimise patient care: interventional study looking at whether a high fibre diet reduces protein-bound uraemic toxins (PBUT) in peritoneal dialysis (PD) patients.

Sponsor

Eastern Health Clinical School

Enrollment

90 participants

Start Date

Oct 19, 2023

Study Type

Interventional

Conditions

Peritoneal Dialysis Renal Failure

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

When the kidneys fail, people often need dialysis to filter waste products from the blood. Peritoneal dialysis (PD) is one type, done at home through the abdomen. Traditional measures of dialysis effectiveness focus on removing small molecules, but researchers now believe that larger protein-bound waste molecules (called uraemic toxins) may be even more important for patient wellbeing and the preservation of whatever kidney function remains. This study will track patients newly starting peritoneal dialysis, measuring levels of these uraemic toxins alongside quality-of-life scores, symptom burden, and kidney function over time. A subgroup will also try a high-fibre diet — since gut bacteria are thought to reduce uraemic toxin production — to see whether diet can make a meaningful difference to toxin levels and patient outcomes. You may be eligible if you are 18 or older and have started peritoneal dialysis within the last 3 months at Eastern Health. Pregnant women, people with active cancer, and those who cannot consent are not eligible. Participation involves blood tests taken at routine clinic visits and completing quality-of-life questionnaires.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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% 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.