Clinical Trial: Anti-Oxidant Effect on Peritoneal Membrane in Peritoneal Dialysis (PD) Patients

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomized Prospective Trial of N-acetyl Cystein in Patients With Peritoneal Dialysis

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 Summary: 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.
Sponsor: Ewha Womans University

Current Primary Outcome: Peritoneal membrane function [ Time Frame: 6 months ]

Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Oxydative stress status [ Time Frame: 6 months ]
    Measurement of oxydative stress status with plasma and RBC (GSH/GSSG, 8-OHdG)
  • Mesothelial cell transformation (Epithelial to Mesenchymal Transition) [ Time Frame: 6 month ]
    Morphology was analysed with peritoneal dialysate isolated mesothelial cell
  • Residual renal function [ Time Frame: 6 month ]
    Changes in residual renal function (ΔKt/Vurea, ΔeGFR)
  • Peritoneal membrane function [ Time Frame: 2 months ]
    Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test


Original Secondary Outcome: Same as current

Information By: Ewha Womans University

Dates:
Date Received: April 23, 2010
Date Started: March 2010
Date Completion: December 2011
Last Updated: April 26, 2010
Last Verified: March 2010