The Clinical Effects of Korean Adapted APD in Automated Peritoneal Dialysis Patients

NCT ID: NCT01997385

Last Updated: 2016-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1075 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

Renal Insufficiency, Chronic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KAPD-C

KAPD-C is a treatment prescribed 2000 mL fill volume per each 4 cycles of dialysis session with an exchange cycle of 90 minutes.

Group Type: ACTIVE_COMPARATOR

KAPD-C

Intervention Type: 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.

KAPD-A

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.

Group Type: EXPERIMENTAL

KAPD-A

Intervention Type: 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.

Interventions

KAPD-C

KAPD-C is a treatment prescribed 2000 mL fill volume per each 4 cycles of dialysis session with an exchange cycle of 90 minutes.

Intervention Type: PROCEDURE

KAPD-A

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• End stage of Renal Disease(ESRD) patients with indication for renal replacement therapy
• D/P Creatinine above 0.5 as evaluated by a 4-hour peritoneal equilibration test(PET) at screening
• Stable on APD and peritonitis-free for at least 4 weeks(run-in phase) in case of incident patients who chose APD
• Peritonitis-free within 4 weeks in case of maintaining patients who treated with APD in current
• Written informed consent to study participation and data submission

Exclusion Criteria

• Planned to kidney transplantation within 5 months
• Patients with ascites because of the progressed cirrhosis of the liver
• Suspected or confirmed pregnancy
• Prior enrolment in another clinical trial

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fresenius Medical Care Korea

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daejoong Kim, Prof.

Role: PRINCIPAL_INVESTIGATOR

Division of Nephrology, Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

KAAPD_01_112013

Identifier Type: -

Identifier Source: org_study_id