Anemia Clinical Trial
The aim of this study is to explore and identify the effects of acetylcysteine, a common mucolytic with anti-oxidant property, on alleviating the damage caused by increased oxidative stress in hemodialysis patients.
Oxidative stress in patients with renal failure is higher than in healthy controls. Once
undergoing hemodialysis (HD) therapy, patients with end-stage renal disease even have more
oxidative stress. Reactive oxygen species (ROS) denature the vital molecules, such as
lipids, proteins, and nucleic acids.
Increased ROS produce oxidized low-density lipoproteins (ox-LDL), which, in turn, induce
atherosclerosis and subsequent cardiovascular disease. Cardiovascular disease is the leading
cause of death of HD patients. On the other hand, ROS damage RBC membrane and cause
hemolysis. Hemolysis exaggerates uremic anemia and results in resistance to erythropoietin
(EPO) therapy.
Acetylcysteine, a common mucolytic, is an antioxidant as well. In vivo experiments,
acetylcysteine has been demonstrated to inhibit the production of ox-LDL by ROS.
Acetylcysteine has also been shown as an effective drug for prevention of contrast
media-induced nephropathy in high-risk patients.
Thus we hypothesize HD patients taking acetylcysteine may have less ox-LDL produced by ROS
and, consequently, lower risk of cardiovascular disease. Moreover, having less damage to RBC
membrane by ROS, HD patients taking acetylcysteine may have milder anemia and better
responsiveness to erythropoietin therapy. Therefore, we plan to conduct a prospective trial,
in which acetylcysteine is administrated to the enrolled HD patients for three months. The
primary goals of the study are to realize the changes of 1) plasma ox-LDL levels, 2) the
anemia status, 3) the responsiveness to EPO therapy, and 4) severity of atherosclerosis. The
secondary goals are to identify the changes of oxidative stress and pro-inflammatory status
in the patients.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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