Randomized Controlled Trial Comparing Residual Kidney Function in Patients Undergoing Three or Four Exchanges CAPD

End Stage Renal Disease Clinical Trial

Official title:

Randomized Controlled Trial Comparing Residual Kidney Function in Patients Undergoing Three or Four Exchanges CAPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01637792
• Other study ID #: 044119620
• Secondary ID: 07QA1404008DZ190
• Status: Completed
• Phase: Phase 4
• First received: July 1, 2012
• Last updated: July 20, 2016
• Start date: June 2004
• Est. completion date: August 2010

Study information

• Verified date: July 2016
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Science and Technology Commission of Shanghai Municipality
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to explore the impacts of different continuous ambulatory peritoneal dialysis (CAPD) dosage (three 2-Liter exchanges CAPD vs. four 2-Liter exchanges CAPD) on residual kidney function, technique survival, patient survival, and peritonitis in incident Chinese peritoneal dialysis patients.

Description:

1. The primary end point for this study was changes in residual kidney function including GFR, daily urine volume (Uvol), and anuria-free survival. GFR and Uvol were evaluated within 1 week before CAPD initiation (the baseline), and then at month 1, 6, 12, 18 and

24. At the same time, body weight, blood pressure, daily net ultrafiltration, dialysis adequacy, peritoneal solute transport rate, and biochemical parameters etc. were assessed. Once an episode of peritonitis or other serious reversible intercurrent illness occurred, all the assessments were delayed one month after being cured. Anuria was termed by daily Uvol permanently less than 100 ml.

2. The secondary end points included technique survival, patient survival and peritonitis. Technique failure was defined as switching to maintenance hemodialysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• incident CAPD patients aged 18 to 80 years

• GFR = 2 ml/min and Uvol = 500 ml/day

Exclusion Criteria:

• have a history of maintenance hemodialysis or renal transplantation

• anticipated life expectancy less than 6 months

• with active malignancy, acute infection, significant heart failure or in other severe conditions

• unable to give informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anuria
• End Stage Renal Disease
• Kidney Failure, Chronic
• Peritonitis

Intervention

Other:
• Three 2-liter exchanges daily CAPD
CAPD regimen of three 2-liter daily exchanges
• Four 2-liter exchanges daily CAPD
CAPD regimen of four 2-liter daily exchagnes

Locations

Country	Name	City	State
China	Renji Hospital, Shanghai Jiao Tong University school of medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (4)

Fang W, Qian J, Lin A, Rowaie F, Ni Z, Yao Q, Bargman JM, Oreopoulos DG. Comparison of peritoneal dialysis practice patterns and outcomes between a Canadian and a Chinese centre. Nephrol Dial Transplant. 2008 Dec;23(12):4021-8. doi: 10.1093/ndt/gfn372. Epub 2008 Sep 12. — View Citation

Lo WK, Jiang Y, Cheng SW, Cheng IK. Survival of CAPD patients in a center using three two-liter exchanges as standard regime. Perit Dial Int. 1996;16 Suppl 1:S163-6. — View Citation

Singhal MK, Bhaskaran S, Vidgen E, Bargman JM, Vas SI, Oreopoulos DG. Rate of decline of residual renal function in patients on continuous peritoneal dialysis and factors affecting it. Perit Dial Int. 2000 Jul-Aug;20(4):429-38. — View Citation

Szeto CC, Lai KN, Yu AW, Leung CB, Ho KK, Mak TW, Li PK, Lam CW. Dialysis adequacy of Asian patients receiving small volume continuous ambulatory peritoneal dialysis. Int J Artif Organs. 1997 Aug;20(8):428-35. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual kidney function including glomerular filtration rate (GFR), daily urine voume (Uvol), and anuria-free survival.	GFR was calculated by the mean of renal clearance of urea and creatinine from a 24-h urine collection. Anuria was termed as consistently Uvol < 100 ml/day for more than a month.	Up to 24 months after CAPD initiation	No
Secondary	Number of participants having technique failure refering to switching to maintenance hemodialyisis		Up to 24 months after CAPD initiation.	Yes
Secondary	Number of participants died		Up to 24 months after CAPD initiation	Yes
Secondary	Episodes of peritonitis		Up to 24 months after CAPD initiation	Yes