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Completed

NCT Number: NCT05698420

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

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.

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Key information

Conditions

Hemodialysis-Associated Pruritus Anemia of Chronic Kidney Disease Depressive Disorder Dyssomnias Malnutrition-Inflammation-Cachexia Syndrome Mental Disorders Mood Disorders Nervous System Diseases Parasomnias Restless Legs Syndrome Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mehmet Akif Inan Training and Research Hospital

Sanliurfa, Karaköprü, 63000, Turkey (Türkiye)

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dialysis using the Theranova-400 device.

Device

Patients receive hemodialysis treatment using the Theranova-400 dialyzer.

Dialysis using the FX80 device.

Device

Patients receive hemodialysis treatment using the FX80 dialyzer.

Primary outcomes

  1. Malnutrition-inflammation score (MIS)

    Time frame: 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.

  2. Malnutrition-inflammation score (MIS)

    Time frame: 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.

  3. Depressive disorder

    Time frame: 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.

  4. Depressive disorder

    Time frame: 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.

  5. Uremic pruritus

    Time frame: 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.

  6. Uremic pruritus

    Time frame: 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.

  7. Restless leg syndrome

    Time frame: 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.

  8. Restless leg syndrome

    Time frame: 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.

  9. Appetite

    Time frame: 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.

  10. Appetite

    Time frame: 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.

  11. Hemoglobin

    Time frame: March 2020

    Hemoglobin levels will be measured on a monthly basis.

  12. Hemoglobin

    Time frame: April 2020

    Hemoglobin levels will be measured on a monthly basis.

  13. Hemoglobin

    Time frame: May 2020

    Hemoglobin levels will be measured on a monthly basis.

  14. Hemoglobin

    Time frame: June 2020

    Hemoglobin levels will be measured on a monthly basis.

  15. Hemoglobin

    Time frame: July 2020

    Hemoglobin levels will be measured on a monthly basis.

  16. Hemoglobin

    Time frame: August 2020

    Hemoglobin levels will be measured on a monthly basis.

  17. Hemoglobin

    Time frame: September 2020

    Hemoglobin levels will be measured on a monthly basis.

  18. Erythropoietin Doses

    Time frame: March 2020

    Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.

  19. Erythropoietin Doses

    Time frame: April 2020

    Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.

  20. Erythropoietin Doses

    Time frame: May 2020

    Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.

  21. Erythropoietin Doses

    Time frame: June 2020

    Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.

  22. Erythropoietin Doses

    Time frame: July 2020

    Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.

  23. Erythropoietin Doses

    Time frame: August 2020

    Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.

  24. Erythropoietin Doses

    Time frame: September 2020

    Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.

  25. Phosphorus levels control

    Time frame: March 2020

    Serum phosphorus levels will be tested on a monthly basis.

  26. Phosphorus levels control

    Time frame: April 2020

    Serum phosphorus levels will be tested on a monthly basis.

  27. Phosphorus levels control

    Time frame: May 2020

    Serum phosphorus levels will be tested on a monthly basis.

  28. Phosphorus levels control

    Time frame: June 2020

    Serum phosphorus levels will be tested on a monthly basis.

  29. Phosphorus levels control

    Time frame: July 2020

    Serum phosphorus levels will be tested on a monthly basis.

  30. Phosphorus levels control

    Time frame: August 2020

    Serum phosphorus levels will be tested on a monthly basis.

  31. Phosphorus levels control

    Time frame: September 2020

    Serum phosphorus levels will be tested on a monthly basis.

  32. Parathyroid hormone levels control

    Time frame: March 2020

    Serum parathyroid hormone levels will be tested on a monthly basis.

  33. Parathyroid hormone levels control

    Time frame: April 2020

    Serum parathyroid hormone levels will be tested on a monthly basis.

  34. Parathyroid hormone levels control

    Time frame: May 2020

    Serum parathyroid hormone levels will be tested on a monthly basis.

  35. Parathyroid hormone levels control

    Time frame: June 2020

    Serum parathyroid hormone levels will be tested on a monthly basis.

  36. Parathyroid hormone levels control

    Time frame: July 2020

    Serum parathyroid hormone levels will be tested on a monthly basis.

  37. Parathyroid hormone levels control

    Time frame: August 2020

    Serum parathyroid hormone levels will be tested on a monthly basis.

  38. Parathyroid hormone levels control

    Time frame: September 2020

    Serum parathyroid hormone levels will be tested on a monthly basis.

Sponsors and collaborators

Lead sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 26, 2023
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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