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Malnutrition and Inflammation in Dialysis Patients in Taiwan

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 August 2005 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00173823
First Posted: September 15, 2005
Last Update Posted: March 13, 2006
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.
Information provided by:
National Taiwan University Hospital
  Purpose

According to the reports of the United States Renal Data System (USRDS), there is a 25% annual mortality rate with nearly 50% of all reported maintenance hemodialysis (HD) patient deaths attributed to atherosclerosis-related complications. Although traditional risk factors of cardiovascular disease (CVD) are common in end-stage renal disease (ESRD) patients, they alone may be insufficient to account for their high prevalence of CVD. Recent evidence demonstrated high plasma homocysteine levels have been established as a risk factor of chronic inflammation and atherosclerosis in patients with ESRD.

Malnutrition and inflammation was associated with poor quality of life, morbidity and mortality. We, the researchers at National Taiwan University Hospital, hope to establish the best predictive profile of HD patient outcome. Thus, we establish several protocols to complete this work.


Condition
Hemodialysis Hypercholesterolemia Malnutrition Inflammation Kidney Failure, Chronic

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Retrospective/Prospective
Official Title: Malnutrition and Inflammation in Taiwan: Prospective Outcome Evaluation Method (MIT-POEM) in Dialysis Patients

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 1500
Study Start Date: June 2004
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • On HD three times a week for more than 3 months (minimizing the confounding effects of residual renal function)

Exclusion Criteria:

  • Malignancy;
  • Obvious infections or inflammatory diseases;
  • Preexisting haematological disorders; and,
  • Clinically significant bleeding, transfusion, hospitalization, surgery, or renal transplantation
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00173823


Locations
Taiwan
National Taiwan University Hospital and collegues Recruiting
Taipei, Taiwan
Contact: Chih-Kang Chiang, MD    +886-23123456 ext 3921    ckchiang@ha.mc.ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chih-Kang Chiang, MD National Taiwan University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00173823     History of Changes
Other Study ID Numbers: 9461700840
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: March 13, 2006
Last Verified: August 2005

Additional relevant MeSH terms:
Inflammation
Hypercholesterolemia
Malnutrition
Renal Insufficiency
Kidney Failure, Chronic
Pathologic Processes
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic