Effect of Different Dialysis Dosage on Prognosis in Maintenance Peritoneal Dialysis Patients

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 4

Conditions: End-stage Renal Disease

Treatments: Drug: 8 L dialysate; Drug: 6 L dialysate

Study type: Interventional

Funder types: Other

Identifiers

NCT00912821

08dz1900501-b

Details and patient eligibility

About

Peritoneal dialysis (PD) is an important model of renal replacement therapy for end-stage renal disease (ESRD) patients. Thus far, evidence for the initiation dosage of PD treatment is lacking, most patients begin their PD with four 2 L exchanges per day. However, many patients have their residual renal function at the initiation of PD, an 8 L dialysate per day will enhance the toxicity of bioincompatible dialysate and increase the economic burden compared with that of 6 L dialysate per day. Thus, the investigators perform a prospective, randomized, controlled, multi-center clinical study. The patients initiation of PD treatment within 6 months are randomized to be assigned to two groups: 6 L of dialysate per day and 8 L of dialysate per day, follow up will be regularly performed until 96 weeks. Clinical outcomes such as mortality, complications and life quality between the two groups will be investigated.

Full description

To investigate the effect, feasibility and safety of 6L of dialysate per day after initiation of peritoneal dialysis (PD), we perform a prospective, randomized, controlled, multi-center clinical study. The patients initiation of PD treatment within 6 months are randomized to be assigned to two groups: 6L of dialysate per day and 8L of dialysate per day, follow up will be regularly performed at baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks, 72 weeks, 84 weeks and 96 weeks. Serum biochemical parameters, Kt/V, residual renal function (RRF), life quality and cardiovascular test will be regularly recorded. Clinical outcomes such as mortality, technique failure, complications and life quality between the two groups will be investigated.

Enrollment: 200 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age from 18 to 80, male or female.
2. End stage renal disease patients (eGFR < 15 ml/min/1.73 m2).
3. Maintenance peritoneal dialysis within 6 months after initiation of PD.
4. With informed consent.

Exclusion criteria

1. Acute renal injury.
2. Patients with an expected follow up less than 6 months sch as renal transplantation.
3. Transferred from hemodialysis or renal transplantation.
4. Residual renal function eGFR less than 1 ml/min.
5. HIV positive.
6. Cancer patients.
7. Unstable organ disease such as active tuberculosis and severe hepatitis. Patients with an expected follow up less than 48 weeks, such as planned kidney transplant.
8. Other conditions regarded as unsuitability by investigator, such as pregnancy, severe malnutrition and recent peritonitis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

8 L dialysate

Active Comparator group

Description:

8 L peritoneal dialysis solution

Treatment:

Drug: 8 L dialysate

6 L dialysate

Experimental group

Description:

6 L peritoneal dialysis solution

Treatment:

Drug: 6 L dialysate