Clinical trial NCT00440869: Effects of N-acetylcysteine on Muscle Fatigue in Hemodialysis
Official title: Effects of N-acetylcysteine on Muscle Fatigue in ESRD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: End-Stage Renal Disease
Dialysis
Hemodialysis
Keywords: N-acetylcysteine
oxidative stress
muscle fatigue
end-stage renal disease
hemodialysis
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2007-02-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: change in quadriceps muscle endurance during intermittent submaximal contractions
timeFrame: 6 days
measure: change in exercise-induced markers of oxidative stress
timeFrame: 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
Study officials:
affiliation: University of California, San Francisco, San Francisco VA Medical Center
name: Kirsten L Johansen, MD
role: PRINCIPAL_INVESTIGATOR
References: