Effects of N-acetylcysteine on Muscle Fatigue in Hemodialysis — NAC  

Hemodialysis Clinical Trial

Official title: Effects of N-acetylcysteine on Muscle Fatigue in ESRD

Status Completed

Clinical Trial Summary

The purposes of the study are to determine whether oxidative stress causes the muscle of dialysis patients to tire more quickly than muscle of people without kidney disease and to determine whether treatment with N-acetylcysteine, an antioxidant, can improve muscle endurance.

Clinical Trial Description

Muscle dysfunction is a major problem for patients with end-stage renal disease (ESRD). Specifically, these patients experience approximately three-fold greater muscle fatigue of the lower extremities during intermittent submaximal contractions than healthy control subjects. Thus, a treatment that could ameliorate muscle fatigue in this population has the potential to increase endurance during activities of daily living and improve quality of life. Dialysis patients have been shown to have high levels of various markers of oxidative stress, and oxidative stress has been associated with excessive muscle fatigue in other patient populations, but this link has not been established in the ESRD population.

Comparisons: The amount of muscle fatigue during intermittent submaximal quadriceps exercise between dialysis patients and controls will be compared. In addition, the degree of exercise-induced increase in markers of oxidative stress in muscle and in plasma will be compared between dialysis patients and controls and between dialysis patients who have received N-acetylcysteine for 6 days and those who have received placebo capsules. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dialysis
• End-Stage Renal Disease
• Hemodialysis
• Kidney Diseases
• Kidney Failure, Chronic

• NCT number: NCT00440869
• Study type: Interventional
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Status: Completed
• Phase: Phase 1
• Start date: March 2007
• Completion date: December 2009