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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Far Eastern Memorial Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anemia Atherosclerosis End-Stage Renal Disease Oxidative Stress Pro-Inflammation Drug: acetylcysteine Phase 4

Detailed Description:

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)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2005
Estimated Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. the changes of plasma ox-LDL levels
  2. the changes of anemia status
  3. the responsiveness to EPO therapy and severity of atherosclerosis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • On HD thrice a week at our HD unit for more than three months
  • Informed consent
  • The dose of EPO and iron supplement is stationary in the previous one month
  • No taking acetylcysteine in previous one month
  • No using vitamin E-bonded dialysis membrane

Exclusion Criteria:

  • Severe liver disease (AST or ALT >40 IU/L), proven malignancy, and severe cardiovascular disease (proved by cardiac catheter or echography examination)
  • Active infection or hospitalization in previous one month
  • Clinically significant bleeding episode in previous one month
  • Taking vitamin C, vitamin E or other known antioxidants.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00247507

Far Eastern Memorial Hospital
Pan-Chiao, Taipei, Taiwan, 220
Sponsors and Collaborators
Far Eastern Memorial Hospital
Principal Investigator: Shih-Ping Hsu, M.D. Far Eastern Memorial Hospital Identifier: NCT00247507     History of Changes
Other Study ID Numbers: 94029
First Posted: November 2, 2005    Key Record Dates
Last Update Posted: October 18, 2006
Last Verified: October 2005

Keywords provided by Far Eastern Memorial Hospital:
End-stage renal disease
Oxidative stress

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Pathologic Processes
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs