Clinical trial NCT05698420: Investigation of the Effects of Medium Cut-off Dialyzers Versus High-Flux Dialyzers on Clinical and Laboratory Parameters of Prevalent Hemodialysis Patients
Official title: Investigation of the Effects of Medium Cut-off Dialyzers Versus High-Flux Dialyzers on Clinical and Laboratory Parameters of Prevalent Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodialysis-Associated Pruritus
Malnutrition-Inflammation-Cachexia Syndrome
Restless Legs Syndrome
Anemia of Chronic Kidney Disease
Depressive Disorder
Lead sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prevalent patients who are receiving hemodialysis treatment three times a week and are otherwise in stable condition.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Malnutrition-inflammation score (MIS)
timeFrame: Prior to randomization, at the start of the study.
measure: Malnutrition-inflammation score (MIS)
timeFrame: At the end of the 6th month after randomization.
measure: Depressive disorder
timeFrame: Prior to randomization, at the start of the study.
measure: Depressive disorder
timeFrame: At the end of the 6th month after randomization.
measure: Uremic pruritus
timeFrame: Prior to randomization, at the start of the study.
measure: Uremic pruritus
timeFrame: At the end of the 6th month after randomization.
measure: Restless leg syndrome
timeFrame: Prior to randomization, at the start of the study.
measure: Restless leg syndrome
timeFrame: At the end of the 6th month after randomization.
measure: Appetite
timeFrame: Prior to randomization, at the start of the study.
measure: Appetite
timeFrame: At the end of the 6th month after randomization.
measure: Hemoglobin
timeFrame: March 2020
measure: Hemoglobin
timeFrame: April 2020
measure: Hemoglobin
timeFrame: May 2020
measure: Hemoglobin
timeFrame: June 2020
measure: Hemoglobin
timeFrame: July 2020
measure: Hemoglobin
timeFrame: August 2020
measure: Hemoglobin
timeFrame: September 2020
measure: Erythropoietin Doses
timeFrame: March 2020
measure: Erythropoietin Doses
timeFrame: April 2020
measure: Erythropoietin Doses
timeFrame: May 2020
measure: Erythropoietin Doses
timeFrame: June 2020
measure: Erythropoietin Doses
timeFrame: July 2020
measure: Erythropoietin Doses
timeFrame: August 2020
measure: Erythropoietin Doses
timeFrame: September 2020
measure: Phosphorus levels control
timeFrame: March 2020
measure: Phosphorus levels control
timeFrame: April 2020
measure: Phosphorus levels control
timeFrame: May 2020
measure: Phosphorus levels control
timeFrame: June 2020
measure: Phosphorus levels control
timeFrame: July 2020
measure: Phosphorus levels control
timeFrame: August 2020
measure: Phosphorus levels control
timeFrame: September 2020
measure: Parathyroid hormone levels control
timeFrame: March 2020
measure: Parathyroid hormone levels control
timeFrame: April 2020
measure: Parathyroid hormone levels control
timeFrame: May 2020
measure: Parathyroid hormone levels control
timeFrame: June 2020
measure: Parathyroid hormone levels control
timeFrame: July 2020
measure: Parathyroid hormone levels control
timeFrame: August 2020
measure: Parathyroid hormone levels control
timeFrame: September 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: Mehmet Akif Inan Training and Research Hospital
state: Karaköprü
Study officials:
affiliation: Mehmet Akif Inan Training and Research Hospital
name: Tuncay Sahutoglu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: