Effects of N-acetylcysteine on Muscle Fatigue in Hemodialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effects of Acetylcysteine on Alleviating Damage of Oxidative Stress in Hemodialysis Patients

NCT00247507

Anemia Atherosclerosis End-Stage Renal Disease +2 more

UNKNOWN PHASE4

Effect of N-Acetylcysteine (NAC) on Creatinine in Chronic Kidney Disease

NCT00506506

Chronic Kidney Disease

COMPLETED PHASE3

Study of N-Acetylcysteine (NAC) and Continuous Renal Replacement Therapy (CRRT) for the Treatment of Rhabdomyolysis

NCT00391911

Rhabdomyolysis

COMPLETED PHASE2

The Effect of Administration on N-Acetylcysteine on Serum Creatinine Levels in Patients With Chronic Kidney Disease

NCT00498342

Chronic Kidney Disease

COMPLETED NA

Optimalization of Nephroprotection Using N-Acetylcysteine

NCT00572663

Chronic Kidney Disease Proteinuria

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

End-Stage Renal Disease Dialysis Hemodialysis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

N-acetylcysteine

Active

Group Type EXPERIMENTAL

N-acetylcysteine

Intervention Type DIETARY_SUPPLEMENT

600 mg po bid

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

bid oral dosing

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

N-acetylcysteine

600 mg po bid

Intervention Type DIETARY_SUPPLEMENT

placebo

bid oral dosing

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes