The Effects of Acetylcysteine on Alleviating Damage of Oxidative Stress in Hemodialysis Patients
|ClinicalTrials.gov Identifier: NCT00247507|
Recruitment Status : Unknown
Verified October 2005 by Far Eastern Memorial Hospital.
Recruitment status was: Active, not recruiting
First Posted : November 2, 2005
Last Update Posted : October 18, 2006
|Condition or disease||Intervention/treatment||Phase|
|Anemia Atherosclerosis End-Stage Renal Disease Oxidative Stress Pro-Inflammation||Drug: acetylcysteine||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||September 2005|
|Estimated Study Completion Date :||December 2005|
- the changes of plasma ox-LDL levels
- the changes of anemia status
- the responsiveness to EPO therapy and severity of atherosclerosis
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00247507
|Far Eastern Memorial Hospital|
|Pan-Chiao, Taipei, Taiwan, 220|
|Principal Investigator:||Shih-Ping Hsu, M.D.||Far Eastern Memorial Hospital|