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The aim of this study is to assess the impact of "adapted" Automated Peritoneal Dialysis(APD) sequentially prescribed shorter and longer dwell exchanges with smaller and larger fill volumes in comparison with "conventional APD" prescribed a standard continuous cycling peritoneal dialysis on the efficacy of dialysis.
It is well known that the efficiency of peritoneal dialysis (PD) varies with the duration of the dwell and the prescribed fill volume. Short dwell ensures adequate UF because the osmotic gradient is maintained while prolonged dwell allows for more solute clearance because the dialysate-to-plasma ratio (D/P) for uremic toxins such as creatinine and phosphate enhances. In terms of intraperitoneal fill volume, large fill volume improves the removal of uremic toxins for two reasons: a larger volume can be drained and therefore the clearance achieved is greater, and the peritoneal surface area available for the exchange is increased. Conversely, small fill volume promotes the process of UF because of the potentially low intraperitoneal pressure (IPP). Overall, choosing the optimal dwell time and exchange volume should promote UF and increase the removal of uremic toxins-urea in particular-to the dialysate.
Thus, this study proposes a new way of giving PD, using a modified version of conventional prescription which firstly uses 2 cycles of short dwell time with a small fill volume to promote UF and subsequently uses 2 cycles of longer dwell time and a larger fill volume to promote removal of uremic toxins from the blood.
Although it was already evaluated the efficiency of this modified prescription by Fischbach et al, the prescription currently prescribed in most Korean hospitals shows some differences in dwell time, fill volume and exchange cycling. The aim of this study is to assess the clinical effect of "Korean Adapted APD" (KAPD-A) compared to "Korean Conventional APD" (KAPD-C).
This is a multicenter, randomized, open-label, parallel controlled study. Patients who meet inclusion criteria will be randomized into each group at the ratio of 1:1. For incident patients, after being stable on APD and peritonitis-free at least 4 weeks, which is called as "run-in period", group 1 will start with 8 weeks of KAPD-C treatment and then cross over to 8 weeks of treatment with KAPD-A while group 2 will be performed on the contrary from KAPD-A to KAPD-C treatment.
Each patient will receive the same total amount of dialysate (8000 mL), given over the same 8-hour duration. First at the inclusion visit called "as baseline", and then visits will take place every 4 weeks for a total of 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KAPD-C | Active Comparator | KAPD-C is a treatment prescribed 2000 mL fill volume per each 4 cycles of dialysis session with an exchange cycle of 90 minutes. |
|
| KAPD-A | Experimental | KAPD-A is a treatment initially prescribed 1500 mL fill volume per each 2 cycles of dialysis session with an exchange cycle of 45 minutes and followed by 2 cycles of 2500 mL fill volume with an exchange cycle of 135 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KAPD-C | Procedure | KAPD-C is a treatment prescribed 2000 mL fill volume per each 4 cycles of dialysis session with an exchange cycle of 90 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in overnight peritoneal ultrafiltration (UF) between KAPD-C and KAPD-A | at 4,8,12,16 weeks from baseline | |
| Difference in weekly peritoneal Kt/V urea between KAPD-C and KAPD-A | at 4,8,12,16 weeks from baseline | |
| Difference in weekly peritoneal creatinine clearance between KAPD-C and KAPD-A | at 4,8,12,16 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in phosphate dialytic removal between KAPD-C and KAPD-A | at 4,8,12,16 weeks from baseline | |
| Difference in corrected for glucose absorption between KAPD-C and KAPD-A | at 4,8,12,16 weeks from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daejoong Kim, Prof. | Division of Nephrology, Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 16, 2018 | |
| Reset | Jan 30, 2019 | |
| Release | Feb 28, 2019 | |
| Unrelease | Mar 11, 2019 | |
| Release | Mar 11, 2019 | |
| Unrelease | Mar 11, 2019 | |
| Release | Mar 20, 2019 | |
| Reset | Jun 20, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 16, 2018 | Jan 30, 2019 | |||
| Feb 28, 2019 | Mar 11, 2019 |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| KAPD-A | Procedure | KAPD-A is a treatment initially prescribed 1500 mL fill volume per each 2 cycles of dialysis session with an exchange cycle of 45 minutes and followed by 2 cycles of 2500 mL fill volume with an exchange cycle of 135 minutes. |
|
| Mar 11, 2019 | Mar 11, 2019 |
| Mar 20, 2019 | Jun 20, 2019 |
| 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 |