End-Stage Kidney Disease, Peritoneal Dialysis
Conditions
Keywords
Antioxidant, Epithelial to Mesenchymal Transition, peritoneal fibrosis, Peritoneal Dialysis, Continuous Ambulatory
Brief summary
Peritoneal fibrosis is one of the major causes of technical failure in patients on peritoneal dialysis (PD) for long period of time. Although the exact mechanisms of peritoneal damage during PD still remain unclear, generation of reactive oxygen species may be responsible for progressive membrane dysfunction. N-acetylcysteine (NAC)is a powerful antioxidant shown to protect peritoneal fibrosis in peritoneal dialysis animal model. In this study the researchers investigated the hypothesis that NAC protect peritoneal membrane damage.
Detailed description
N-Acetylcysteine (NAC) is known to be relatively safe and beneficial in peritoneal dialysis patient at a dose of 1200 mg per day. Patients will be randomly assigned to NAC and control group and prescribed according to the protocol. At 2 and 6 month, Peritoneal equilibrium test (PET) will be performed with blood sampling.
Interventions
DRUGN-acetylcysteine
N-acetylcysteine (200 mg/capsule) 1200 mg/day (600 mg bid) for 6 months
Sponsors
Ewha Womans University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Maintenance peritoneal dialysis at least 3 months * Patients who are able and willing to understand, sign and date an informed consent document, and authorize access to protected health information
Exclusion criteria
* Episode of peritonitis at least 3 months * Episodes of admission due to other disease at lease 3 months * Liver disease * Allergic history with N-acetylcysteine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peritoneal membrane function | 6 months | Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxydative stress status | 6 months | Measurement of oxydative stress status with plasma and RBC (GSH/GSSG, 8-OHdG) |
| Mesothelial cell transformation (Epithelial to Mesenchymal Transition) | 6 month | Morphology was analysed with peritoneal dialysate isolated mesothelial cell |
| Residual renal function | 6 month | Changes in residual renal function (ΔKt/Vurea, ΔeGFR) |
| Peritoneal membrane function | 2 months | Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test |
Countries
South Korea
Contacts
Primary ContactMina Yu, MD
Backup ContactHyun-Jung Kim, NR
Outcome results
None listed