An interventional study of medium cut-off (MCO) dialysis membrane and Dietary fiber mixture (Plantago Psyllium and Inulin) in End Stage Renal Disease, Haemodialysis and Diet, Healthy, sponsored by University Medical Centre Ljubljana. Status unknown at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by University Medical Centre Ljubljana · Not applicable, Interventional, and Treatment
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.
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:
Measurement of the study end-points will be carried out at the end of 2-week wash-in period, each 4-week period and at the end of 4 week wash-out period.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 50 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
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Exclusion Criteria:
4 weeks of dialysis with MCO (Theranova) membrane then dialysis for 4 weeks with MCO membrane and increased fiber intake
Device: medium cut-off (MCO) dialysis membrane · Dietary Supplement: Dietary fiber mixture (Plantago Psyllium and Inulin) · Dietary Supplement: Sodium propionate
4 weeks of high-flux membrane haemodiafiltration and 4 weeks of high-flux membrane haemodiafiltration and increased fiber intake
Dietary Supplement: Dietary fiber mixture (Plantago Psyllium and Inulin) · Dietary Supplement: Sodium propionate
Medium cut-off dialysis (MCO) membrane is a dialysis membrane with a higher molecular weight retention onset and similar cut-off as standard high-flux dialysis membranes. It is capable of providing increased clearance of medium sized uremic toxins and some plasma proteins (cytokines, inflammatory mediators).
Also known as: Theranova dialysis membrane (Baxter AG)
Dietary fiber (Psyllium 69% and Inulin 30% mixture) added to the meals in the dose of 5g BID for 4 weeks in the second phase of the study.
Also known as: Kolon3aktiv fiber powder (manufacturer TOPNATUR s.r.o., Czech republic)
Sodium propionate (a short-chain fatty acid) added to the meals in the dose of 500 mg BID in the second phase in the study.
Serum concentration of uremic toxin p-cresol sulphate
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.
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).
Serum concentration of uremic toxins indoxyl sulfate
Blood for the laboratory measurements of serum total indoxyl sulfate concentration will be taken from the arterial line before the start of midweek hemodialysis procedure.
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).
Serum concentration of uremic toxin trimethylamine N-oxide (TMAO)
Blood for the laboratory measurements of serum TMAO concentration will be taken from the arterial line before the start of midweek hemodialysis procedure.
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).
Serum concentration of beta2-microglobulin
Blood for the laboratory measurements of serum beta2-microglobulin concentration will be taken from the arterial line before the start of midweek hemodialysis procedure.
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).
Serum concentration of phosphate
Blood for the laboratory measurements of serum phosphate concentration will be taken from the arterial line before the start of midweek hemodialysis procedure.
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).
Serum urea concentration
Blood for the laboratory measurements of serum urea concentration will be taken from the arterial line before the start of midweek hemodialysis procedure.
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).
Serum albumin concentration
Blood for the laboratory measurements of serum albumin concentration will be taken from the arterial line before the start of midweek hemodialysis procedure.
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).
Dialysis symptom index questionnaire score
A validated questionnaire of 30 questions regarding the dialysis symptoms experienced during the last week. Unabbreviated scale title: Dialysis symptom index. Each of 30 items (symptoms) is ranked on a 5-point Likert scale. Minimal score: 0. Maximum score: 150. Higher scores mean worse outcomes (worse symptom burden).
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).
Time to finish 10 repetition sit to stand test
This validated test measures lower limb strength. Participants are required to stand up and sit down 10 times from an armless chair as quickly as possible, the outcome is the time needed to perform the test.
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).
Physical activity level as measured by accelerometry
Number of accelerometer counts in 7 days.
Time frame: At the end of wash-in period (basal sample-baseline), at the end of second phase (8 weeks after baseline), at the end of wash-out period (12 weeks after baseline).
Plan to share: Yes — Plan to share IPD that underline results published in the manuscripts reporting study results.
Supporting information: Study protocol, Sap, Icf, Csr
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University Medical Centre Ljubljana