Randomized Cross-Over Comparison of Medium Cut-Off and High-Flux Hemodialysis Membranes

Patients receiving maintenance hemodialysis are at increased risk of cardiovascular disease, chronic inflammation, endothelial dysfunction, and impaired quality of life. Medium cut-Off (MCO) hemodialysis membranes have been developed to enhance the removal of middle-molecular-weight uremic toxins compared with conventional high-flux membranes, which may improve inflammatory status and cardiovascular health. The aim of this study is to compare the effects of MCO and high-flux hemodialysis membranes on inflammatory biomarkers and cardiovascular function in adult patients receiving maintenance hemodialysis. The primary outcomes are changes in serum interleukin-6 (IL-6) and vascular cell adhesion molecule-1 (VCAM-1) levels. Secondary outcomes include arterial stiffness assessed by pulse wave velocity (PWV), body composition assessed by Body Composition Monitor (BCM), handgrip strength, and patient-reported outcomes including quality of life, pruritus, and pain scores. This is a prospective, randomized, open-label, two-sequence, two-period crossover study conducted at Gazi University Faculty of Medicine. Thirty adult hemodialysis patients will be randomized to one of two treatment sequences. Participants in Sequence A will receive MCO dialysis membranes for the first 3 months followed by high-flux membranes for the next 3 months. Participants in Sequence B will receive high-flux membranes for the first 3 months followed by MCO membranes for the next 3 months. Blood samples and clinical assessments will be performed at baseline, month 3, and month 6. The study is expected to provide evidence regarding the effects of different dialysis membrane technologies on inflammation and cardiovascular health and may contribute to optimizing membrane selection in routine hemodialysis practice.

Inclusion Criteria: * Age 18 to 80 years. * Receiving maintenance hemodialysis for at least 6 months. * Clinically stable and receiving thrice-weekly hemodialysis. * Able to comply with study procedures, questionnaires, and scheduled assessments. * Able and willing to provide written informed consent. Exclusion Criteria: * Acute infection at screening or enrollment. * Major surgery within the previous 3 months. * Active malignancy requiring ongoing treatment. * Terminal illness with limited life expectancy. * Physical or cognitive impairment preventing completion of study procedures or questionnaires. * Inability or unwillingness to provide written informed consent.