Effects of N-acetylcysteine on Muscle Fatigue in Hemodialysis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of N-acetylcysteine on Muscle Fatigue in ESRD

Conditions
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End-Stage Renal Disease, Dialysis, Hemodialysis

Intervention / Treatment
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* Dietary Supplement: N-acetylcysteine
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age greater than 18 years undergoing hemodialysis for 3 months or more or healthy control without kidney disease Exclusion Criteria: inability to give informed consent diagnosis of diabetes mellitus musculoskeletal contraindication to exercise infection requiring intravenous antibiotics within 2 months hospitalization within 2 months ingestion of antioxidant supplements within one month requirement for systemic anticoagulation estimated GFR <60 ml/min/1.73 m2 for healthy controls

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N-acetylcysteine<br>Active | Dietary Supplement: N-acetylcysteine<br>* 600 mg po bid<br>|
| Placebo Comparator: placebo<br>placebo | Dietary Supplement: placebo<br>* bid oral dosing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in quadriceps muscle endurance during intermittent submaximal contractions |  | 6 days | 
| change in exercise-induced markers of oxidative stress |  | 8 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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N-acetylcysteine, oxidative stress, muscle fatigue, end-stage renal disease, hemodialysis