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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2005 by Far Eastern Memorial Hospital.
Recruitment status was  Active, not recruiting
Information provided by:
Far Eastern Memorial Hospital Identifier:
First received: October 31, 2005
Last updated: October 17, 2006
Last verified: October 2005
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 Intervention Phase
End-Stage Renal Disease
Oxidative Stress
Drug: acetylcysteine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Far Eastern Memorial Hospital:

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

Study Start Date: September 2005
Estimated Study Completion Date: December 2005
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

No publications provided Identifier: NCT00247507     History of Changes
Other Study ID Numbers: 94029
Study First Received: October 31, 2005
Last Updated: October 17, 2006
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Arterial Occlusive Diseases
Cardiovascular Diseases
Pathologic Processes
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Vascular Diseases
Anti-Infective Agents
Antiviral Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses processed this record on November 24, 2015