NCT00173823

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

March 13, 2006

Status Verified

August 1, 2005

First QC Date

September 13, 2005

Last Update Submit

March 10, 2006

Conditions

HemodialysisHypercholesterolemiaMalnutritionInflammationKidney Failure, Chronic

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Malignancy;
  • Obvious infections or inflammatory diseases;
  • Preexisting haematological disorders; and,
  • Clinically significant bleeding, transfusion, hospitalization, surgery, or renal transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital and collegues

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

HypercholesterolemiaMalnutritionInflammationKidney Failure, Chronic

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesNutrition DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease Attributes

Study Officials

  • Chih-Kang Chiang, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

June 1, 2004

Last Updated

March 13, 2006

Record last verified: 2005-08

Locations

TW(1)