Combination of Medium Cut-off Dialyzer Membrane and Diet Modification to Alleviate Residual Uremic Syndrome of Dialysis Patients
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Serum concentration of uremic toxin p-cresol sulphate
Study Overview
Brief Summary
The study will compare achieved levels of protein-bound uremic toxins with dialysis using a medium cut-off membrane compared to the treatment by online haemodiafiltration with a high-flux dialysis membrane. In the second phase of the study dietary fiber and short-chain fatty acid intake will be increased to verify a possible additional reduction in the levels of protein bound uremic toxins.
Detailed Description
The investigators will carry out a prospective interventional randomised study to compare achieved serum concentrations of selected protein bound uremic toxins by dialysis with a medium cut-off membrane (Theranova, Baxter AG, USA) and online hemodiafiltration with a standard "high-flux" dialysis membrane. In the second phase, both dialysis purification methods will be supplemented by a change in the diet with increase of the daily intake of dietary fiber to 30g and addition of a short-chain fatty acid propionate in the dose of 1 g daily.
The main outcome of the study is the serum concentration of p-cresol sulphate. Secondary outcome is the serum concentration of indoxyl-sulphate and trimethylamine-N-oxide (TMAO). Serum albumin concentration and lean body weight of patients represent safety outcomes for this study.
This investigator-initiated research project has been entirely planned and will be conducted by the clinical researchers in a tertiary University Medical Center Ljubljana.
The study will include 50 chronic prevalent stable dialysis patients in the following periods:
- 2 weeks of wash-in period with standard bicarbonate haemodialysis and standard high-flux dialysis membrane,
- then the patients will be randomized in a 1:1 ratio to either one of the two study arms:
- (interventional study arm) 4 weeks of dialysis with medium cut-off (Theranova) membrane (first phase), then dialysis for 4 weeks with the same membrane and increased fiber intake (second phase),
- (control study arm) 4 weeks of dialysis with a high-flux membrane using on-line haemodiafiltration (first phase) and 4 weeks of high-flux membrane haemodiafiltration and increased fiber intake (second phase),
- finally, all patients will undergo a 4 week wash-out period with a standard bicarbonate haemodialysis using standard high-flux dialysis membrane identical to wash-in period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patient on chronic hemodialysis or hemodiafiltration for at least 12 weeks,
- •age 18 years old or more,
- •a functioning arteriovenous fistula or graft as a permanent dialysis vascular access,
- •being able to give an informed consent to participate in the survey;
Exclusion Criteria
- •planned kidney transplantation, transition to peritoneal dialysis or to another dialysis center within 12 weeks of the start of the study,
- •active chronic inflammation (e.g., an active autoimmune disease or an open wound), chronic ongoing infection or cancer in last 4 weeks,
- •acute febrile illness in last 4 weeks,
- •new cardiovascular or neurovascular event in last 4 weeks,
- •a need for hospitalization in the last 4 weeks,
- •clinically evident malnutrition and/or body mass index of 19 kg/m2 and/or loss of body weight for 5% in last 3 months,
- •immunosuppressive treatment,
- •expected survival of less than 1 year,
- •pregnancy or breast-feeding,
- •indication for dietary supplements to increase calorie and / or protein intake,
- •specific indication for carrying out hemodiafiltration instead of hemodialysis as per attending physician,
- •serum albumin concentration <32 g/l at screening to enter the study,
- •inability to follow the study diet or test procedures,
- •rapid reduction of residual renal function in the period prior to entry into the study,
- •intolerant of on-line haemodiafiltration (infusion intolerance);
Arms & Interventions
Interventional arm - MCO dialysis membrane
4 weeks of dialysis with MCO (Theranova) membrane then dialysis for 4 weeks with MCO membrane and increased fiber intake
Intervention: medium cut-off (MCO) dialysis membrane (Device)
Interventional arm - MCO dialysis membrane
4 weeks of dialysis with MCO (Theranova) membrane then dialysis for 4 weeks with MCO membrane and increased fiber intake
Intervention: Dietary fiber mixture (Plantago Psyllium and Inulin) (Dietary Supplement)
Control arm - high-flux membrane haemodiafiltration
4 weeks of high-flux membrane haemodiafiltration and 4 weeks of high-flux membrane haemodiafiltration and increased fiber intake
Intervention: Dietary fiber mixture (Plantago Psyllium and Inulin) (Dietary Supplement)
Control arm - high-flux membrane haemodiafiltration
4 weeks of high-flux membrane haemodiafiltration and 4 weeks of high-flux membrane haemodiafiltration and increased fiber intake
Intervention: Sodium propionate (Dietary Supplement)
Interventional arm - MCO dialysis membrane
4 weeks of dialysis with MCO (Theranova) membrane then dialysis for 4 weeks with MCO membrane and increased fiber intake
Intervention: Sodium propionate (Dietary Supplement)
Outcomes
Primary Outcomes
Serum concentration of uremic toxin p-cresol sulphate
Time Frame: At the end of wash-in period (basal sample-baseline), at the end of first phase (4 weeks after baseline), at the end of second phase (8 weeks after baseline), at the end of wash-out period (12 weeks after baseline).
Blood for the laboratory measurements of serum total p-cresol sulphate concentration will be taken from the arterial line before the start of midweek hemodialysis procedure.
Secondary Outcomes
- Serum concentration of uremic toxins indoxyl sulfate(At the end of wash-in period (basal sample-baseline), at the end of first phase (4 weeks after baseline), at the end of second phase (8 weeks after baseline), at the end of wash-out period (12 weeks after baseline).)
Investigators
Jernej Pajek
Associate Professor, MD, PhD
University Medical Centre Ljubljana