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.
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 Type
OBSERVATIONAL
Enrollment
50
Patients receive hemodialysis treatment using the Theranova-400 dialyzer.
Patients receive hemodialysis treatment using the FX80 dialyzer.
Mehmet Akif Inan Training and Research Hospital
Sanliurfa, Karaköprü, Turkey (Türkiye)
Malnutrition-inflammation score (MIS)
At the start of the study, the malnutrition-inflammation score will be recorded. This score ranges from 0 to 30, with higher scores indicating worse outcomes.
Time frame: Prior to randomization, at the start of the study.
Malnutrition-inflammation score (MIS)
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.
Time frame: At the end of the 6th month after randomization.
Depressive disorder
At the start of the study, the Beck's depression scale will be recorded. This score ranges from 0 to 63, with higher scores indicating worse depression.
Time frame: Prior to randomization, at the start of the study.
Depressive disorder
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.
Time frame: At the end of the 6th month after randomization.
Uremic pruritus
At the start 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.
Time frame: Prior to randomization, at the start of the study.
Uremic pruritus
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.
Time frame: At the end of the 6th month after randomization.
Restless leg syndrome
At the start 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.
Time frame: Prior to randomization, at the start of the study.
Restless leg syndrome
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.
Time frame: At the end of the 6th month after randomization.
Appetite
At the start 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.
Time frame: Prior to randomization, at the start of the study.
Appetite
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.
Time frame: At the end of the 6th month after randomization.
Hemoglobin
Hemoglobin levels will be measured on a monthly basis.
Time frame: March 2020
Hemoglobin
Hemoglobin levels will be measured on a monthly basis.
Time frame: April 2020
Hemoglobin
Hemoglobin levels will be measured on a monthly basis.
Time frame: May 2020
Hemoglobin
Hemoglobin levels will be measured on a monthly basis.
Time frame: June 2020
Hemoglobin
Hemoglobin levels will be measured on a monthly basis.
Time frame: July 2020
Hemoglobin
Hemoglobin levels will be measured on a monthly basis.
Time frame: August 2020
Hemoglobin
Hemoglobin levels will be measured on a monthly basis.
Time frame: September 2020
Erythropoietin Doses
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
Time frame: March 2020
Erythropoietin Doses
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
Time frame: April 2020
Erythropoietin Doses
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
Time frame: May 2020
Erythropoietin Doses
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
Time frame: June 2020
Erythropoietin Doses
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
Time frame: July 2020
Erythropoietin Doses
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
Time frame: August 2020
Erythropoietin Doses
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
Time frame: September 2020
Phosphorus levels control
Serum phosphorus levels will be tested on a monthly basis.
Time frame: March 2020
Phosphorus levels control
Serum phosphorus levels will be tested on a monthly basis.
Time frame: April 2020
Phosphorus levels control
Serum phosphorus levels will be tested on a monthly basis.
Time frame: May 2020
Phosphorus levels control
Serum phosphorus levels will be tested on a monthly basis.
Time frame: June 2020
Phosphorus levels control
Serum phosphorus levels will be tested on a monthly basis.
Time frame: July 2020
Phosphorus levels control
Serum phosphorus levels will be tested on a monthly basis.
Time frame: August 2020
Phosphorus levels control
Serum phosphorus levels will be tested on a monthly basis.
Time frame: September 2020
Parathyroid hormone levels control
Serum parathyroid hormone levels will be tested on a monthly basis.
Time frame: March 2020
Parathyroid hormone levels control
Serum parathyroid hormone levels will be tested on a monthly basis.
Time frame: April 2020
Parathyroid hormone levels control
Serum parathyroid hormone levels will be tested on a monthly basis.
Time frame: May 2020
Parathyroid hormone levels control
Serum parathyroid hormone levels will be tested on a monthly basis.
Time frame: June 2020
Parathyroid hormone levels control
Serum parathyroid hormone levels will be tested on a monthly basis.
Time frame: July 2020
Parathyroid hormone levels control
Serum parathyroid hormone levels will be tested on a monthly basis.
Time frame: August 2020
Parathyroid hormone levels control
Serum parathyroid hormone levels will be tested on a monthly basis.
Time frame: September 2020
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