NCT05698420

Investigation of the Effects of Medium Cut-off Dialyzers Versus High-Flux Dialyzers on Clinical and Laboratory Parameters of Prevalent Hemodialysis Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, the investigators aimed to observe the effects of medium cut-off dialysis filters and high-flux dialysis filters on malnutrition inflammation score, uremic itching, restless leg syndrome, anemia, and ESA treatment, which are prominent complications in hemodialysis, and routine follow-up parameters.

Detailed description

The study is designed as a single-center, prospective, observational research. A total of 50 stable-course chronic hemodialysis patients over 18 years of age and treated for at least 3 months will be included in the study and the study period will be planned for 12 months. 25 of the 50 chronic hemodialysis patients planned to be included in the study will use MCO-membrane and the other 25 will use high-flux membrane. The distribution of patients to the high-flux membrane and MCO membrane groups will be done randomly (sequentially single-pair number method). Then, the standard 12-hour (3x4 hours/week) hemodialysis treatment will continue. At the beginning of the study (0.), at the end of the third (3.) month and at the end of the sixth (6.) month; Monthly laboratory tests routinely performed on hemodialysis patients (tests routinely performed in hemodialysis patient follow-up) 5 ml blood samples will be taken from the hemodialysis set to determine the levels of medium-large molecule-weight toxins-wastes and inflammatory parameters before and after dialysis, and the sera will be separated and stored at -80oC for use at the end of the study. Automatic blood pressure measurement will be performed before and after hemodialysis to evaluate arterial stiffness. The Malnutrition Inflammation Score will be applied to evaluate the nutritional status (the MIS form is given in the appendix) Visual Analog Scale will be used for appetite Visual Analog Scale will be used for uremic pruritus Depression scale screening (Beck's scale)

Conditions

• Hemodialysis-Associated Pruritus
• Malnutrition-Inflammation-Cachexia Syndrome
• Restless Legs Syndrome
• Anemia of Chronic Kidney Disease
• Depressive Disorder

Interventions

Type	Name	Description
DEVICE	Dialysis using the Theranova-400 device.	Patients receive hemodialysis treatment using the Theranova-400 dialyzer.
DEVICE	Dialysis using the FX80 device.	Patients receive hemodialysis treatment using the FX80 dialyzer.

Timeline

• Start date: 2020-03-01
• Primary completion: 2020-09-30
• Completion: 2020-10-31
• First posted: 2023-01-26
• Last updated: 2024-05-14

Locations

1 site across 1 country: Turkey (Türkiye)