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

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.

Study Overview

• Status: Completed
• Conditions: End-stage Renal Disease
• Intervention / Treatment: Drug: 8 L dialysate; Drug: 6 L dialysate

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200001
    • Renji Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 8 L dialysate; 8 L peritoneal dialysis solution	Drug: 8 L dialysate; 8 L peritoneal dialysis solution
Experimental: 6 L dialysate; 6 L peritoneal dialysis solution	Drug: 6 L dialysate; 6 L peritoneal dialysis solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
clinical outcome including mortality and technical failure	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: June 1, 2009
• First Submitted That Met QC Criteria: June 1, 2009
• First Posted (Estimate): June 3, 2009

Study Record Updates

• Last Update Posted (Estimate): October 13, 2016
• Last Update Submitted That Met QC Criteria: October 12, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Peritoneal dialysis; Renal Replacement Therapy
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Pharmaceutical Solutions; Dialysis Solutions
• Other Study ID Numbers: 08dz1900501-b