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

Effect of Different Dialysis Dosage on Prognosis in Maintenance Peritoneal Dialysis Patients - A Prospective, Randomized, Controlled, Multi-center Clinical Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00912821

Enrollment

200

Registered

2009-06-03

Start date

2009-03-31

Completion date

2012-07-31

Last updated

2016-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage Renal Disease

Keywords

Renal Replacement Therapy, Peritoneal dialysis

Brief summary

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.

Detailed 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.

Interventions

DRUG6 L dialysate

6 L peritoneal dialysis solution

DRUG8 L dialysate

8 L peritoneal dialysis solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
clinical outcome including mortality and technical failure	2 years

Secondary

Measure	Time frame
complications including cardiovascular disease, nutritional and inflammation status, calcium and phosphorus level, anemia and life quality	2 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026