Disorders Associated With Peritoneal Dialysis
Conditions
Brief summary
This prospective, randomized, controlled, multi-center clinical trial will evaluate the validity and security of 2500ml Huaren Peritoneal Dialysate compared with normal 2000ml peritoneal dialysate.
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 most of them used imported dialysate, of which the price carried a great burden. Now, cheaper domestic dialysate is accessed to the ESRD patients in china, but the efficacy and safety of which are not fully clear. And according to researches from Hongkong, 6000ml of dialysate every day is able to. Thus, we presume 3 bags of 2500ml Huaren dialysate will satisfy the everyday need of an normal Asian. This will be a prospective, randomized, controlled, multi-center study. Patients in treatment group will use 2-3 bags of 2500ml Huaren dialysate in the daytime and keep 1 bag of 2500ml Huaren dialysate in the night, while those in control group will use 3-4 bags of normal 2000ml dialysate in the daytime and keep 1 bag of 2000ml dialysate in the night for 12 weeks. After followed-up for 12 weeks, the adequacy of PD, residual kidney function , peritoneum function and QOL of patients will be evaluated.
Interventions
OTHER2500ml Huaren peritoneal dialysate
use 2-3 bags of 2500ml Huaren dialysate in the daytime and keep 1 bag of 2500ml Huaren dialysate in the night
OTHER2000ml peritoneal dialysate
use 3-4 bags of normal 2000ml dialysate in the daytime and keep 1 bag of 2000ml dialysate in the night
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adequacy of dialysis (kt/v) | up to 8 weeks | kt/v |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peritoneal function (Peritoneal equilibration test) | up to 6 months | Peritoneal equilibration test |
| Residual kidney function (Residual kidney kt/v) | up to 6 months | Residual kidney kt/v |
Countries
China
Contacts
Primary ContactZongpei Jiang, M.D. & Ph.D.
Outcome results
None listed