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

Overview

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.

Full Title of Study: “A Randomized Prospective Trial of N-acetyl Cystein in Patients With Peritoneal Dialysis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2010

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

  • Drug: N-acetylcysteine
    • N-acetylcysteine (200 mg/capsule) 1200 mg/day (600 mg bid) for 6 months

Arms, Groups and Cohorts

  • No Intervention: Control
    • Age and sex matched peritoneal dialysis patients
  • Experimental: N-acetylcysteine
    • N-acetylcysteine in stable peritoneal dialysis patients

Clinical Trial Outcome Measures

Primary Measures

  • Peritoneal membrane function
    • Time Frame: 6 months
    • Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ewha Womans University
  • Provider of Information About this Clinical Study
    • Nephrology, Ewha Womans University Mokdong Hospital
  • Overall Official(s)
    • Duk-Hee Kang, MD. PhD., Principal Investigator, Ewha Womans University
  • Overall Contact(s)
    • Mina Yu, MD, +82-2-2650-2562, yuelizabeth@hanmail.net

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