The Effect of Combining Medium Cut Off Polyarylethersulfone-polyvinylpyrrolidone Dialysis Membrane and Diet Modification on Reducing of Inflammation Response
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Serum concentration of inflammatory mediator interleukin-6 (IL-6).
Study Overview
Brief Summary
The investigators purpose is to research the impact of the simultaneous use of a new dialysis membrane with higher permeability for medium and protein bound uraemic toxins (medium cut-off dialysis membrane Theranova®) combined with diet modification to reduce the level of inflammation in chronic dialysis patients. The investigators hypothesize that the use of a medium-cut off dialysis membrane and dietary modification work synergistically and cause a significant and clinically meaningful reduction in inflammation levels compared to on-line hemodiafiltration with a high-flux dialysis membrane.
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 Interleukin-6. Secondary outcome is the serum concentration of interleukin-10, serum amyloid A, High-sensitivity C-reactive protein, total leukocyte count and plasma concentration of bacterial 16s rDNA. 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 hospital 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
- •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)
Arms & Interventions
Interventional arm - MCO dialysis membrane
4 weeks of dialysis with MCO 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 membrane, then dialysis for 4 weeks with MCO membrane and increased fiber intake
Intervention: Dietary fiber mixture (Plantago Psyllium 69% and Inulin 30%) (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 69% and Inulin 30%) (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 membrane, then dialysis for 4 weeks with MCO membrane and increased fiber intake
Intervention: Sodium propionate (Dietary Supplement)
Outcomes
Primary Outcomes
Serum concentration of inflammatory mediator interleukin-6 (IL-6).
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 interleukin-6 concentration will be taken from the arterial line before the start of midweek hemodialysis procedure.
Secondary Outcomes
- Serum concentration of inflammatory mediator High-sensitivity C-reactive protein (hs-CRP).(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
MD, PhD
University Medical Centre Ljubljana