The Effect of Combining Medium Cut Off Dialysis Membrane and Diet Modification on Reducing of Inflammation Response

Launched by UNIVERSITY MEDICAL CENTRE LJUBLJANA · Feb 5, 2020

Keywords

ClinConnect Summary

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 concentra...

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Eligibility criteria

• 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
• • Acute febrile inless 4 weeks prior to study inclusion
• • Active chronic inflammation (e.g., an active autoimmune disease or an open wound), chronic ongoing infection or cancer
• • New cardiovascular or cerebrovascular event 4 weeks prior to study inclusion
• • Clinically malnourishet patient and/or BMI below 19 kg/m2 and/or loss of more the 5% of body mass in the 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 after 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)