Investigation of the Effects of Medium Cut-off Dialyzers Versus High-Flux Dialyzers on Clinical and Laboratory Parameters of Prevalent Hemodialysis Patients
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2020
CompletedFirst Submitted
Initial submission to the registry
January 5, 2023
CompletedFirst Posted
Study publicly available on registry
January 26, 2023
CompletedMay 14, 2024
May 1, 2024
7 months
January 5, 2023
May 12, 2024
Conditions
Outcome Measures
Primary Outcomes (38)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
At the end of the 6th month after randomization.
Hemoglobin
Hemoglobin levels will be measured on a monthly basis.
March 2020
Hemoglobin
Hemoglobin levels will be measured on a monthly basis.
April 2020
Hemoglobin
Hemoglobin levels will be measured on a monthly basis.
May 2020
Hemoglobin
Hemoglobin levels will be measured on a monthly basis.
June 2020
Hemoglobin
Hemoglobin levels will be measured on a monthly basis.
July 2020
Hemoglobin
Hemoglobin levels will be measured on a monthly basis.
August 2020
Hemoglobin
Hemoglobin levels will be measured on a monthly basis.
September 2020
Erythropoietin Doses
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
March 2020
Erythropoietin Doses
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
April 2020
Erythropoietin Doses
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
May 2020
Erythropoietin Doses
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
June 2020
Erythropoietin Doses
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
July 2020
Erythropoietin Doses
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
August 2020
Erythropoietin Doses
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
September 2020
Phosphorus levels control
Serum phosphorus levels will be tested on a monthly basis.
March 2020
Phosphorus levels control
Serum phosphorus levels will be tested on a monthly basis.
April 2020
Phosphorus levels control
Serum phosphorus levels will be tested on a monthly basis.
May 2020
Phosphorus levels control
Serum phosphorus levels will be tested on a monthly basis.
June 2020
Phosphorus levels control
Serum phosphorus levels will be tested on a monthly basis.
July 2020
Phosphorus levels control
Serum phosphorus levels will be tested on a monthly basis.
August 2020
Phosphorus levels control
Serum phosphorus levels will be tested on a monthly basis.
September 2020
Parathyroid hormone levels control
Serum parathyroid hormone levels will be tested on a monthly basis.
March 2020
Parathyroid hormone levels control
Serum parathyroid hormone levels will be tested on a monthly basis.
April 2020
Parathyroid hormone levels control
Serum parathyroid hormone levels will be tested on a monthly basis.
May 2020
Parathyroid hormone levels control
Serum parathyroid hormone levels will be tested on a monthly basis.
June 2020
Parathyroid hormone levels control
Serum parathyroid hormone levels will be tested on a monthly basis.
July 2020
Parathyroid hormone levels control
Serum parathyroid hormone levels will be tested on a monthly basis.
August 2020
Parathyroid hormone levels control
Serum parathyroid hormone levels will be tested on a monthly basis.
September 2020
Study Arms (2)
The Theranova 400 group, also known as the MCO group.
Patients undergoing maintenance hemodialysis will receive dialysis treatment using the Theranova 400 device.
The FX80 group, also known as the high-flux group.
Patients undergoing maintenance hemodialysis will receive dialysis treatment using the FX80 device.
Interventions
Patients receive hemodialysis treatment using the Theranova-400 dialyzer.
Patients receive hemodialysis treatment using the FX80 dialyzer.
Eligibility Criteria
Prevalent patients who are receiving hemodialysis treatment three times a week and are otherwise in stable condition.
You may qualify if:
- Chronic hemodialysis patients
- Patients continuing the hemodialysis program for at least 3 months
- Patients over 18 years of age
You may not qualify if:
- Patients with advanced heart failure, malignancy, terminal illness
- Patients with active infectious disease
- Acute hemodialysis patients
- Patients vascular access dysfunction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mehmet Akif Inan Training and Research Hospital
Sanliurfa, Karaköprü, 63000, Turkey (Türkiye)
Biospecimen
Serum and plasma extracts from venous blood samples were stored at -80C of the hospital.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tuncay Sahutoglu, M.D.
Mehmet Akif Inan Training and Research Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 5, 2023
First Posted
January 26, 2023
Study Start
March 1, 2020
Primary Completion
September 30, 2020
Study Completion
October 31, 2020
Last Updated
May 14, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share