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

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 4

Conditions: Anuria; Peritonitis; End Stage Renal Disease

Treatments: Other: Four 2-liter exchanges daily CAPD; Other: Three 2-liter exchanges daily CAPD

Study type: Interventional

Funder types: Other

Identifiers

NCT01637792

07QA14040 (Other Grant/Funding Number)

044119620

08DZ1900501 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 139 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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139 participants in 2 patient groups

Three 2-liter exchanges group

Experimental group

Description:

A group of randomly assigned patients undergoing three 2-liter exchanges daily CAPD.

Treatment:

Other: Three 2-liter exchanges daily CAPD

Four 2-liter exchanges group

Active Comparator group

Description:

A group of randomly assigned patients undergoing four 2-liter exchanges daily CAPD.

Treatment:

Other: Four 2-liter exchanges daily CAPD