Anemia of Chronic Kidney Disease, Depressive Disorder, Hemodialysis-Associated Pruritus, Malnutrition-Inflammation-Cachexia Syndrome, Restless Legs Syndrome
Conditions
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)
Interventions
DEVICEDialysis using the Theranova-400 device.
Patients receive hemodialysis treatment using the Theranova-400 dialyzer.
DEVICEDialysis using the FX80 device.
Patients receive hemodialysis treatment using the FX80 dialyzer.
Sponsors
Sanliurfa Mehmet Akif Inan Education and Research Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin | March 2020 | Hemoglobin levels will be measured on a monthly basis. |
| Malnutrition-inflammation score (MIS) | Prior to randomization, at the start of the study. | 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. |
| Depressive disorder | Prior to randomization, at the start of the study. | 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. |
| Uremic pruritus | Prior to randomization, at the start of the study. | 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. |
| Restless leg syndrome | Prior to randomization, at the start of the study. | 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. |
| Appetite | Prior to randomization, at the start of the study. | 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. |
| Erythropoietin Doses | March 2020 | Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis. |
| Phosphorus levels control | March 2020 | Serum phosphorus levels will be tested on a monthly basis. |
| Parathyroid hormone levels control | March 2020 | Serum parathyroid hormone levels will be tested on a monthly basis. |
Countries
Turkey (Türkiye)
Outcome results
None listed