Clinical trial NCT01637792: Randomized Controlled Trial Comparing Residual Kidney Function in Patients Undergoing Three or Four Exchanges CAPD
Official title: Randomized Controlled Trial Comparing Residual Kidney Function in Patients Undergoing Three or Four Exchanges CAPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: End Stage Renal Disease
Anuria
Peritonitis
Keywords: peritoneal dialysis
dose
residual kidney function
technique survival
patient survival
peritonitis
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Residual kidney function including glomerular filtration rate (GFR), daily urine voume (Uvol), and anuria-free survival.
timeFrame: Up to 24 months after CAPD initiation
Secondary outcomes:
measure: Number of participants having technique failure refering to switching to maintenance hemodialyisis
timeFrame: Up to 24 months after CAPD initiation.
measure: Number of participants died
timeFrame: Up to 24 months after CAPD initiation
measure: Episodes of peritonitis
timeFrame: Up to 24 months after CAPD initiation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiao Tong University school of medicine
state: Shanghai
Study officials:
affiliation: Renal Division, Renji Hospital, Shanghai Jiaotong University School of Medicine
name: Wei Fang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.