Evidence map›Paper›PMID 28085888›Full record

Trial reportPloS one2017

Medium Cut-Off (MCO) Membranes Reduce Inflammation in Chronic Dialysis Patients-A Randomized Controlled Clinical Trial.

Daniel Zickler, Ralf Schindler, Kevin Willy, Peter Martus, Michael Pawlak, Markus Storr, Michael Hulko, Torsten Boehler, Marcus A Glomb, Kristin Liehr and 7 more

6 registry-linked trialsOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 61 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 2 pooled it
7.6field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02084381 nacompletednot on this map

Permeability Enhancement to Reduce Chronic Inflammation _ Medium Cut Off (MCO) (Study no 1502)

TypeinterventionalSponsorVantive Health LLCRan2014 to 2015Enrolled50ConditionsChronic Kidney Failure, Chronic InflammationArmsMCO-Ci 400, Revaclear 400
NCT03270371 naunknown statusnot on this map

Medium-term Modulation of the Inflammatory Profile by Medium-cut Off Membranes in Patients With End Stage Renal Disease

TypeinterventionalSponsorTechnical University of MunichRan2017 to 2019Enrolled50ConditionsCardiovascular Diseases, End Stage Renal DiseaseArmsMedium cut off dialysis, Standard High Flux Dialyzer
NCT04247867 naunknown statusnot on this mapstarted 2020, after this paper: background citation

Combination of Medium Cut-off Dialyzer Membrane and Diet Modification to Alleviate Residual Uremic Syndrome of Dialysis Patients

TypeinterventionalSponsorUniversity Medical Centre LjubljanaRan2020 to 2022Enrolled50ConditionsEnd Stage Renal Disease, Haemodialysis, Diet, HealthyArmsmedium cut-off (MCO) dialysis membrane, Dietary fiber mixture (Plantago Psyllium and Inulin), Sodium propionate
NCT04260412 naunknown statusnot on this mapstarted 2020, after this paper: background citation

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

TypeinterventionalSponsorUniversity Medical Centre LjubljanaRan2020 to 2022Enrolled50ConditionsEnd Stage Renal Disease, Haemodialysis, Diet, Healthy, Chronic InflammationArmsmedium cut-off (MCO) dialysis membrane, Dietary fiber mixture (Plantago Psyllium 69% and Inulin 30%), Sodium propionate
NCT04786535 naunknown statusnot on this mapstarted 2021, after this paper: background citation

Crossover Study of Three Groups Comparing the Efficacy of Uremic Toxins Clearance of Expanded Hemodialysis With Two Hemodialysis Membranes for Conventional Hemodialysis and Hemodiafiltration

TypeinterventionalSponsorInstituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranRan2021 to 2022Enrolled23ConditionsEnd Stage Renal DiseaseArmsExpanded Hemodialysis, High-flux Conventional Hemodialysis, Hemodiafiltration
NCT07679763 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

Randomized Cross-Over Evaluation of Medium Cut-Off and High-Flux Hemodialysis Membranes on Inflammation and Cardiovascular Function in Maintenance Hemodialysis Patients

TypeinterventionalSponsorGazi UniversityRan2026 to 2027Enrolled30ConditionsEnd Stage Kidney Disease (ESKD), Hemodialysis, Cardiovascular Diseases (CVD), InflammationArmsMedium Cut-Off Hemodialysis Membrane, High-Flux Hemodialysis Membrane
3 · Its place in the literature

Who cites it

61 citing papers in PubMed, 2 syntheses or guidelines pooled it, 115 citations in OpenAlex.

  1. Pooled it
  2. Efficacy of medium cut-off dialyzers and comparison with high-flux dialyzers in patients on maintenance hemodialysis: A systematic review and meta-analysis.Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy · 2022
    Pooled it
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1 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 5 institutions in 1 country.

Daniel ZicklerCharité-Universitaetsmedizin Berlin, Campus Virchow Clinic, Department of Nephrology and Intensive Care Medicine, Berlin, Germany.
Ralf SchindlerCharité-Universitaetsmedizin Berlin, Campus Virchow Clinic, Department of Nephrology and Intensive Care Medicine, Berlin, Germany.
Kevin WillyCharité-Universitaetsmedizin Berlin, Campus Virchow Clinic, Department of Nephrology and Intensive Care Medicine, Berlin, Germany.
Peter MartusInstitute for Clinical Epidemiology and Applied Biometry, University of Tübingen, Tübingen, Germany.
Michael PawlakNMI Technology Transfer GmbH, Reutlingen, Germany.
Markus StorrDepartment of Research and Development, Gambro Dialysatoren GmbH, Hechingen, Germany.
Michael HulkoDepartment of Research and Development, Gambro Dialysatoren GmbH, Hechingen, Germany.
Torsten BoehlerDepartment of Research and Development, Gambro Dialysatoren GmbH, Hechingen, Germany.
Marcus A GlombInstitute for Chemistry, Food Chemistry, Martin-Luther-University Halle, Halle an der Saale, Germany.
Kristin LiehrInstitute for Chemistry, Food Chemistry, Martin-Luther-University Halle, Halle an der Saale, Germany.
Christian HenningInstitute for Chemistry, Food Chemistry, Martin-Luther-University Halle, Halle an der Saale, Germany.
Markus TemplinNMI Technology Transfer GmbH, Reutlingen, Germany.
Bogusz TrojanowiczDepartment of Internal Medicine II, Martin-Luther-University Halle, Halle an der Saale, Germany.
Christof UlrichDepartment of Internal Medicine II, Martin-Luther-University Halle, Halle an der Saale, Germany.
Kristin WernerDepartment of Research and Development, Gambro Dialysatoren GmbH, Hechingen, Germany.
Roman FiedlerDepartment of Internal Medicine II, Martin-Luther-University Halle, Halle an der Saale, Germany.
Matthias GirndtDepartment of Internal Medicine II, Martin-Luther-University Halle, Halle an der Saale, Germany.
Martin Luther University Halle-Wittenberg · DEBaxter (Germany) · DECharité - Universitätsmedizin Berlin · DENatural and Medical Sciences Institute · DEUniversity of Tübingen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo increase the removal of middle-sized uremic toxins a new membrane with enhanced permeability and selectivity, called Medium Cut-Off membrane (MCO-Ci) has been developed that at the same time ensures the retention of albumin. Because many middle-sized substances may contribute to micro-inflammation we hypothesized that the use of MCO-Ci influences the inflammatory state in hemodialysis patients.

methodsThe randomized crossover trial in 48 patients compared MCO-Ci dialysis to High-flux dialysis of 4 weeks duration each plus 8 weeks extension phase. Primary endpoint was the gene expression of TNF-α and IL-6 in peripheral blood mononuclear cells (PBMCs), secondary endpoints were plasma levels of specified inflammatory mediators and cytokines.

resultsAfter four weeks of MCO-Ci the expression of TNF-α mRNA (Relative quantification (RQ) from 0.92 ± 0.34 to 0.75 ± 0.31, -18.5%, p<0.001)-α and IL-6 mRNA (RQ from 0.78 ± 0.80 to 0.60 ± 0.43, -23.1%, p<0.01) was reduced to a significantly greater extent than with High-flux dialyzers (TNF mRNA-RQ: -14.3%; IL-6 mRNA-RQ: -3.5%). After retransformation of logarithmically transformed data, measurements after MCO were reduced to 82% of those after HF (95% CI 74%-91%). 4 weeks use of MCO-Ci resulted in long-lasting change in plasma levels of several cytokines and other substances with a significant decrease for sTNFR1, kappa and lambda free light chains, urea and an increase for Lp-PLA2 (PLA2G7) compared to High-flux. Albumin levels dropped significantly after 4 weeks of MCO dialysis but increased after additional 8 weeks of MCO dialysis. Twelve weeks treatment with MCO-Ci was well tolerated regarding the number of (S)AEs. In the extension period levels of CRP, TNF-α-mRNA and IL-6 mRNA remained stable in High-flux as well as in MCO-Ci.

conclusionsMCO-Ci dialyzers modulate inflammation in chronic HD patients to a greater extent compared to High-flux dialyzers. Transcription of pro-inflammatory cytokines in peripheral leukocytes is markedly reduced and removal of soluble mediators is enhanced with MCO dialysis. Serum albumin concentrations stabilize after an initial drop. These results encourage further trials with longer treatment periods and clinical endpoints.

Indexed as

Membranes, Artificialbeta 2-MicroglobulinCross-Over StudiesCytokinesFemaleHumansInflammationKidney Failure, ChronicMaleMiddle AgedRenal Dialysisbeta 2-MicroglobulinCytokinesMembranes, Artificial

Identifiers

PMID28085888
PMCPMC5234772
OpenAlexW2576775040

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.