Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00411177
Status:
COMPLETED
Last Update Posted:
2013-09-09
First Post:
2006-12-12
Brief Title:
Comparison of Post-dilution On-line Hemodiafiltration and Hemodialysis
Sponsor:
Ercan OK
Organization:
Ege University
Study Overview
Official Title:
Comparison of Post-dilution On-line Hemodiafiltration and Hemodialysis TURKISH HDF STUDY
Status:
COMPLETED
Status Verified Date:
2013-09
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:
This study aims to compare high-efficiency post-dilution on-line hemodiafiltration and high-flux hemodialysis regarding mortality hospitalization rate several clinical and laboratory parameters and required medications
The investigators hypothesize that high-efficiency post-dilution on-line hemodiafiltration may provide better outcome less morbidity higher quality of life and lesser requirement of medications
The investigators hypothesize that high-efficiency post-dilution on-line hemodiafiltration may provide better outcome less morbidity higher quality of life and lesser requirement of medications
Detailed Description:
The proposed controlled randomized study aims to compare high-efficiency post-dilution on-line hemodiafiltration and high-flux hemodialysis regarding mortality hospitalization rate several clinical and laboratory parameters and required medications
Seven hundred and eighty HD patients will be taken into the study The study will last for two years with an intermediate analysis at the first year The patients will be randomly placed in two groups
1 Post-dilution on-line hemodiafiltration
2 High-flux hemodialysis
In both groups FX series high-flux helixone membranes will be used duration of each session 240 minutes and blood flow rates 250-400 mlmin ONLINEplus integrated Fresenius 4008S machines will be used for on-line post-dilution HDF Substitution volume will be above 15 liters in hemodiafiltration sessions
Echocardiography for determination of left ventricular geometry pulse wave velocity analysis to assess arterial stiffness evaluation of nutritional and inflammatory state assessment of life quality depression and cost analysis will be performed
Seven hundred and eighty HD patients will be taken into the study The study will last for two years with an intermediate analysis at the first year The patients will be randomly placed in two groups
1 Post-dilution on-line hemodiafiltration
2 High-flux hemodialysis
In both groups FX series high-flux helixone membranes will be used duration of each session 240 minutes and blood flow rates 250-400 mlmin ONLINEplus integrated Fresenius 4008S machines will be used for on-line post-dilution HDF Substitution volume will be above 15 liters in hemodiafiltration sessions
Echocardiography for determination of left ventricular geometry pulse wave velocity analysis to assess arterial stiffness evaluation of nutritional and inflammatory state assessment of life quality depression and cost analysis will be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None