A Study of Domestic Automated Peritoneal Dialysis Machine

Overview

This prospective, randomized, controlled, multi-center clinical trial will evaluate the validity and security of domestic APD machine compared with the patients followed CAPD.

Full Title of Study: “Validity and Security of Domestic Automated Peritoneal Dialysis Machine: A Prospective, Randomized, Controlled, Multi-Center Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2015

Detailed Description

Peritoneal dialysis (PD) is one of important way of renal replacement treatment worldwide. In China, about 40,000 patients suffered from end stage renal disease treated with PD, and almost of them followed continuous ambulatory peritoneal dialysis (CAPD) because of the expensive price of import automated PD (APD) machines although the higher clearance of solute, lower rate of PD related peritonitis and higher quality of life (QOL) in patients treated with APD compared those with CAPD. Now, cheaper domestic APD machines ( PDGO, Fuzhou, China) are accessed to the ESRD patients in china, but the efficacy and safety of which are not fully clear. This will be a prospective, randomized, controlled, multi-center study. Patients in treatment group will receive APD while those in control group will receive CAPD for 8 weeks. After followed-up for 8 weeks, the adequacy of PD, residual kidney function , peritoneum function and QOL of patients will be evaluated.

Interventions

  • Other: APD
    • PDGO APD machines used in the PD patients for 8 weeks
  • Other: CAPD
    • CAPD used in the PD Patients for 8 weeks

Arms, Groups and Cohorts

  • Experimental: A APDGroup
    • PDGO APD machines used in the PD patients for 8 weeks
  • Active Comparator: B CAPDGroup
    • CAPD used in the PD Patients for 8 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Adequacy of dialysis
    • Time Frame: up to 8 weeks
    • kt/v

Secondary Measures

  • Residual kidney function
    • Time Frame: up to 6 months
    • Residual kidney kt/v
  • Peritoneal function
    • Time Frame: up to 6 months
    • Peritoneal equilibration test

Participating in This Clinical Trial

Inclusion Criteria

1. The duration of PD is more than 1 month.

2. The age is range from 18 to 80 years old.

3. The patient can be treated with regular PD in home.

4. The volume of peritoneal dialysate is from 8L to 10 L in 1 day.

5. The patient can be visited regularly.

6. The patient must be freely given informed consent

Exclusion Criteria

1. Peritonitis was happened within 1 month

2. The KT/V<1.7

3. Infections in the exit or tunnel

4. With tumors.

5. With low transport of peritoneum.

6. With mental and behavior disorders.

7. With acute renal failure

8. Hemodialysis meanwhile

9. With heart failure( NYHA III-IV ) or cardio- cerebrovascular events

10. Attending other clinical trails

11. Refused to give informed consent Exit criteria

(1)Stop PD for more than 10 days (2)The patient demand to quit from the RCT (3)With serious adverse events.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sun Yat-sen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yanhong Deng, Sun Yat-sen University – Sun Yat-sen University
  • Overall Official(s)
    • Zongpei Jiang, M.D. & Ph.D., Principal Investigator, The Sixth Affiliated Hospital,Sun Yat-Sen University
  • Overall Contact(s)
    • Zongpei Jiang, M.D. & Ph.D., 8620-38379727, jx.home@medmail.com.cn

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