Malnutrition and Inflammation in Dialysis Patients in Taiwan

Inflammation Clinical Trial

Official title:

Malnutrition and Inflammation in Taiwan: Prospective Outcome Evaluation Method (MIT-POEM) in Dialysis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00173823
• Other study ID #: 9461700840
• Status: Recruiting
• Phase: N/A
• First received: September 13, 2005
• Last updated: March 10, 2006
• Start date: June 2004

Study information

• Verified date: August 2005
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Hemodialysis
• Hypercholesterolemia
• Inflammation
• Kidney Failure, Chronic
• Malnutrition
• Renal Insufficiency

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital and collegues	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan,