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| Name | Class |
|---|---|
| Boryung Pharmaceutical Co., Ltd | INDUSTRY |
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Online hemodiafiltration (HDF) may improve clinical outcome in end-stage renal disease. The supported mechanism is the improved clearance of uremic toxins by convective transporter. However, It has not been elucidated which convection volume is optimal, especially in Asia. A total of 60 participants receiving conventional hemodialysis will be randomly assigned to receive either high dose convective volume (33-43 L/treatment) post-dilution online HDF or standard dose (16.8-21.5 L/treatment) for 24 weeks. The primary outcome is the change of serum β2 microglobulin levels between baseline and after 24 weeks. The secondary outcomes will include changes in the nutritional markers, inflammatory markers, and blood pressure from baseline to after treatment.
This would be the first multicenter prospective, randomized controlled trial to determine whether large convective volume improves the treatment efficacy in Korean patients undergoing post-dilution online HDF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Dose online HDF | Active Comparator | Proposed target convection volume; 16.8-21.5 L/treatment (70-90 mL/min) |
|
| High Dose online HDF | Experimental | Proposed target convection volume; 33-43 L/treatment (140-180 mL/min). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Dose Online HDF | Procedure | Convection volume; 33-43 L/treatment (140-180 mL/min) |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes in the serum concentration of β2 microglobulin | between baseline and 24 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Dialysis Adequacy | Kt/V by the single pool variable volume formula. | 24 weeks |
| Inflammatory markers | C-reactive protein (CRP), interleukin-6, tumor necrosis factor-α. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sung Gyun Kim, MD | Contact | +82-10-3586-8561 | imnksk@gmail.com | |
| Soo Jin Kim, MD | Contact | +82-10-8722-8078 | dongangagy@lycos.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Won-Yong Cho, MD | Korea University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Sacred Heart Hospital | Anyang-si | Gyeonggi-do | South Korea |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Standard Dose Online HDF | Procedure | convection volume; 16.8-21.5 L/treatment (70-90 mL/min) |
|
|
| 24 weeks |
| Nutritional status | normalized protein nitrogen appearance rate, serum albumin, serum protein, subjective global assessment (SGA) | 24 weeks |
| Intradialytic hypotension | Number of episode of symptomatic hypotension | 24 weeks |
| Quality of Life | SF-36-K (Korean version) | baseline and 24 weeks after treatment |
| Chung-Ang University Hospital | Seoul | South Korea |
|
| Korea University Anam Hospital | Seoul | South Korea |
|
| Seoul National University Hospital | Seoul | South Korea |
|
| Shamyook Medical Center | Seoul | South Korea |
|
| Yonsei University Gangnam Severance Hospital | Seoul | South Korea |
|
| 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 |