This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2005 by Far Eastern Memorial Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
Information provided by:
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00247507
First received: October 31, 2005
Last updated: October 17, 2006
Last verified: October 2005
  Purpose
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
Anemia Atherosclerosis End-Stage Renal Disease Oxidative Stress Pro-Inflammation Drug: acetylcysteine Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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.

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00247507

Locations
Taiwan
Far Eastern Memorial Hospital
Pan-Chiao, Taipei, Taiwan, 220
Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
Principal Investigator: Shih-Ping Hsu, M.D. Far Eastern Memorial Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00247507     History of Changes
Other Study ID Numbers: 94029
Study First Received: October 31, 2005
Last Updated: October 17, 2006

Keywords provided by Far Eastern Memorial Hospital:
Anemia
atherosclerosis
End-stage renal disease
Erythropoietin
Hemodialysis
Oxidative stress
Pro-inflammation

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

ClinicalTrials.gov processed this record on June 23, 2017