Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05698420
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2023-01-05
Brief Title:
Investigation of the Effects of Medium Cut-off Dialyzers Versus High-Flux Dialyzers on Clinical and Laboratory Parameters of Prevalent Hemodialysis Patients
Sponsor:
Sanliurfa Mehmet Akif Inan Education and Research Hospital
Organization:
Sanliurfa Mehmet Akif Inan Education and Research Hospital
Study Overview
Official Title:
Investigation of the Effects of Medium Cut-off Dialyzers Versus High-Flux Dialyzers on Clinical and Laboratory Parameters of Prevalent Hemodialysis Patients
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 hoursweek 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 Becks scale
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 Becks scale
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None