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| Name | Class |
|---|---|
| Fresenius Medical Care North America | INDUSTRY |
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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 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:
In both groups, FX series high-flux helixone membranes will be used, duration of each session 240 minutes, and blood flow rates 250-400 ml/min. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-dilution on-line hemodiafiltration | Active Comparator | Post-dilution on-line hemodiafiltration |
|
| High-flux hemodialysis | Other | High-flux hemodialysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| post-dilution on-line hemodiafiltration | Procedure | post-dilution on-line hemodiafiltration, 3 times a week 4 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| composite of overall mortality and new cardiovascular events to include myocardial infarction, stroke, revascularization, and unstable angina pectoris requiring hospitalization. | two years |
| Measure | Description | Time Frame |
|---|---|---|
| cardiovascular mortality | two years | |
| hospitalization rate | two years | |
| intradialytic complications including hypotension and cramp |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ercan Ok, MD | Ege University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ege University School of Medicine | Bornova | İzmir | 35100 | Turkey (Türkiye) | ||
| FMC Clinics Turkey |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D007249 | Inflammation |
| D017379 | Hypertrophy, Left Ventricular |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| high flux hemodialysis | Procedure | High-flux hemodialysis, 3 times a week 4 hours |
|
|
| two years |
| health-related quality of life, depression burden, cognitive function | two years |
| required medications | two years |
| changes in blood pressure, left ventricular geometry, arterial stiffness, post-dialysis body weight, upper mid-arm circumference, hematocrit and related rHu-EPO doses, the levels of phosphorus, albumin, lipid parameters, hsCRP, and β-2 microglobulin | two years |
| postdialysis total body water determined by bioimpedance analysis | two years |
| Adana |
| 01000 |
| Turkey (Türkiye) |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006984 | Hypertrophy |
| D020763 | Pathological Conditions, Anatomical |