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

Completed

• Conditions: Hemodialysis-Associated Pruritus; Restless Legs Syndrome; Depressive Disorder; Malnutrition-Inflammation-Cachexia Syndrome; Anemia of Chronic Kidney Disease
• Interventions: Device: Dialysis using the FX80 device.; Device: Dialysis using the Theranova-400 device.

• Registration Number: NCT05698420
• Lead Sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital

Brief 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)

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2020-09-30
• Study Completion: 2020-10-31
• Study First Submitted: 2023-01-05
• Study First Submitted QC: 2023-01-13
• Study First Posted: 2023-01-26
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-12
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Chronic hemodialysis patients
• Patients continuing the hemodialysis program for at least 3 months
• Patients over 18 years of age

Exclusion Criteria

• Patients with advanced heart failure, malignancy, terminal illness
• Patients with active infectious disease
• Acute hemodialysis patients
• Patients vascular access dysfunction

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The FX80 group, also known as the high-flux group.	Dialysis using the FX80 device.	Patients undergoing maintenance hemodialysis will receive dialysis treatment using the FX80 device.
The Theranova 400 group, also known as the MCO group.	Dialysis using the Theranova-400 device.	Patients undergoing maintenance hemodialysis will receive dialysis treatment using the Theranova 400 device.

Primary Outcome Measures

Name	Time	Method
Malnutrition-inflammation score (MIS)	At the end of the 6th month after randomization.	The malnutrition-inflammation score will be recorded at the conclusion of the study. This score ranges from 0 to 30, with higher scores indicating worse outcomes.
Erythropoietin Doses	September 2020	Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
Phosphorus levels control	September 2020	Serum phosphorus levels will be tested on a monthly basis.
Parathyroid hormone levels control	September 2020	Serum parathyroid hormone levels will be tested on a monthly basis.
Depressive disorder	At the end of the 6th month after randomization.	At the conclusion of the study, the Beck's depression scale will be recorded. This score ranges from 0 to 63, with higher scores indicating worse depression.
Hemoglobin	September 2020	Hemoglobin levels will be measured on a monthly basis.
Uremic pruritus	At the end of the 6th month after randomization.	At the conclusion of the study, the visual analog scale for pruritus will be recorded. This score ranges from 0 to 10, with higher scores indicating worse itching.
Restless leg syndrome	At the end of the 6th month after randomization.	At the conclusion of the study, the Restless Leg Syndrome screening questionnaire will be administered. This score ranges from 0 to 40, with higher scores indicating worse symptoms.
Appetite	At the end of the 6th month after randomization.	At the conclusion of the study, the visual analog scale of appetite will be recorded. This score ranges from 0 to 5, with higher scores indicating better appetite.

Trial Locations

Locations (1)

Mehmet Akif Inan Training and Research Hospital; 🇹🇷 Şanlıurfa, Karaköprü, Turkey