Effect of Different Dialysis Dosage on Prognosis in Maintenance Peritoneal Dialysis Patients
Primary Purpose
End-stage Renal Disease
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
6 L dialysate
8 L dialysate
Sponsored by
About this trial
This is an interventional treatment trial for End-stage Renal Disease focused on measuring Renal Replacement Therapy, Peritoneal dialysis
Eligibility Criteria
Inclusion Criteria:
- Age from 18 to 80, male or female.
- End stage renal disease patients (eGFR < 15 ml/min/1.73 m2).
- Maintenance peritoneal dialysis within 6 months after initiation of PD.
- With informed consent.
Exclusion Criteria:
- Acute renal injury.
- Patients with an expected follow up less than 6 months sch as renal transplantation.
- Transferred from hemodialysis or renal transplantation.
- Residual renal function eGFR less than 1 ml/min.
- HIV positive.
- Cancer patients.
- 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.
- Other conditions regarded as unsuitability by investigator, such as pregnancy, severe malnutrition and recent peritonitis.
Sites / Locations
- Renji Hospital, Shanghai Jiao Tong University school of medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
8 L dialysate
6 L dialysate
Arm Description
8 L peritoneal dialysis solution
6 L peritoneal dialysis solution
Outcomes
Primary Outcome Measures
clinical outcome including mortality and technical failure
Secondary Outcome Measures
complications including cardiovascular disease, nutritional and inflammation status, calcium and phosphorus level, anemia and life quality
Full Information
NCT ID
NCT00912821
First Posted
June 1, 2009
Last Updated
October 12, 2016
Sponsor
Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00912821
Brief Title
Effect of Different Dialysis Dosage on Prognosis in Maintenance Peritoneal Dialysis Patients
Official Title
Effect of Different Dialysis Dosage on Prognosis in Maintenance Peritoneal Dialysis Patients - A Prospective, Randomized, Controlled, Multi-center Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease
Keywords
Renal Replacement Therapy, Peritoneal dialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
8 L dialysate
Arm Type
Active Comparator
Arm Description
8 L peritoneal dialysis solution
Arm Title
6 L dialysate
Arm Type
Experimental
Arm Description
6 L peritoneal dialysis solution
Intervention Type
Drug
Intervention Name(s)
6 L dialysate
Intervention Description
6 L peritoneal dialysis solution
Intervention Type
Drug
Intervention Name(s)
8 L dialysate
Intervention Description
8 L peritoneal dialysis solution
Primary Outcome Measure Information:
Title
clinical outcome including mortality and technical failure
Time Frame
2 years
Secondary Outcome Measure Information:
Title
complications including cardiovascular disease, nutritional and inflammation status, calcium and phosphorus level, anemia and life quality
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age from 18 to 80, male or female.
End stage renal disease patients (eGFR < 15 ml/min/1.73 m2).
Maintenance peritoneal dialysis within 6 months after initiation of PD.
With informed consent.
Exclusion Criteria:
Acute renal injury.
Patients with an expected follow up less than 6 months sch as renal transplantation.
Transferred from hemodialysis or renal transplantation.
Residual renal function eGFR less than 1 ml/min.
HIV positive.
Cancer patients.
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.
Other conditions regarded as unsuitability by investigator, such as pregnancy, severe malnutrition and recent peritonitis.
Facility Information:
Facility Name
Renji Hospital, Shanghai Jiao Tong University school of medicine
City
Shanghai
ZIP/Postal Code
200001
Country
China
12. IPD Sharing Statement
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Effect of Different Dialysis Dosage on Prognosis in Maintenance Peritoneal Dialysis Patients
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