Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis

Sisli Hamidiye Etfal Training and Research Hospital50 enrolled

Overview

Double blinded, randomized controlled trial evaluating medium cut-off dialyzer compared to high flux dialyzer in ironic hemodialysis patients over a 6 months period with 3 months crossovers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Kidney Failure Renal Insufficiency, Chronic Dialysis Related Complication

Interventions

Medium cut-offDEVICE

All the dialysis sessions in this arm will be performed with the medium cut-off membrane (MCO) manufactured by Baxter International Corp. membrane for three months. This membrane will exclusively be used in hemodialysis. After third month, all patients will be switched to high-flux membrane manufactured by Fresenius. Modalities of hemodialysis : Blood flow: 300-400 mL/min; Dialysate flow: 500-800 mL/min

High-FluxDEVICE

All the dialysis sessions in this arm will be performed with the high-flux membrane manufactured by Fresenius for three months. This membrane will exclusively be used in hemodialysis. After third month, all patients will be switched to MCO manufactured by Baxter International Corp. Modalities of hemodialysis : Blood flow: 300-400 mL/min; Dialysate flow: 500-800 mL/min

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients who are older than 18 years and younger than 65 years * patient with end-stage renal disease, hemodialysis more than 6 months * patients under hemodialysis with high-flux dialyzer more than 3 months * patients willing to participate after given fair and clear information about study Exclusion Criteria: * patients living with Hepatitis B or C, * patients with malignancy * patients under immunosuppressive treatment * patients with autoimmune diseases such as systemic lupus erythematosus, etc. * patients with active infections * patients planned to have a kidney transplantation in 6 months * patients having vascular access problems * patients planned to transfer to another center

Locations (1)

Sisli Hamidiye Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye)

Outcomes

Primary Outcomes

Comparison of pre and post-dialysis of Interleukin (IL) 17-A

Comparison of pre and post-dialysis of IL-17A

Time frame: 3 months

Secondary Outcomes

Comparison of pre and post-dialysis of IL-10

Time frame: 3 months

Comparison of pre and post-dialysis of Interferon (IFN) gama

Comparison of pre and post-dialysis of IFN gama

Time frame: 3 months

Comparison of pre and post-dialysis necrosis factor (TNF) alpha

Comparison of pre and post-dialysis of TNF alpha

Time frame: 3 months

Comparison of pre and post-dialysis of IL-4

Time frame: 3 months

Comparison of pre and post-dialysis of Urea

Time frame: 3 months

Comparison of pre and post-dialysis of creatinine

Time frame: 3 months

Comparison of pre and post-dialysis of beta2 microglobulin

Time frame: 3 months

Comparison of pre and post-dialysis of free light chain kappa

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.