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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Age and sex matched peritoneal dialysis patients | |
| N-acetylcysteine | Experimental | N-acetylcysteine in stable peritoneal dialysis patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetylcysteine | Drug | N-acetylcysteine (200 mg/capsule) 1200 mg/day (600 mg bid) for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peritoneal membrane function | Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Oxydative stress status | Measurement of oxydative stress status with plasma and RBC (GSH/GSSG, 8-OHdG) | 6 months |
| Mesothelial cell transformation (Epithelial to Mesenchymal Transition) | Morphology was analysed with peritoneal dialysate isolated mesothelial cell |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mina Yu, MD | Contact | +82-2-2650-2562 | yuelizabeth@hanmail.net | |
| Hyun-Jung Kim, NR | Contact | +82-2-2650-5497 | 40739@eumc.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Duk-Hee Kang, MD. PhD. | Ewha Womans University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ewha Womans University Mokdong Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D056627 | Peritoneal Fibrosis |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| 6 month |
| Residual renal function | Changes in residual renal function (ΔKt/Vurea, ΔeGFR) | 6 month |
| Peritoneal membrane function | Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test | 2 months |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |