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

Ewha Womans University

Status and phase: Unknown; Phase 4

Conditions: End-Stage Kidney Disease; Peritoneal Dialysis

Treatments: Drug: N-acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT01111422

Ewha 219-3-40

Details and patient eligibility

About

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 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Control

No Intervention group

Description:

Age and sex matched peritoneal dialysis patients

N-acetylcysteine

Experimental group

Description:

N-acetylcysteine in stable peritoneal dialysis patients

Treatment:

Drug: N-acetylcysteine