Clinical Trials Directory

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UnknownNCT01945320

The Effects Nutrition Status and Body Composition on HD Patients' Outcome

Status
Unknown
Phase
Study type
Observational
Enrollment
250 (estimated)
Sponsor
National Taiwan University Hospital · Academic / Other
Sex
All
Age
20 Years – 90 Years
Healthy volunteers
Not accepted

Summary

A prospective long-term follow up of hemodialysis (HD) patients' outcome correlates with nutritional status and body composition. We will evaluate the body composition change among HD patients every three months with bioelectrical impedance analysis (BIA). The change of body composition will correlated with other clinical data including nutritional, inflammatory parameters and survival.

Detailed description

Wasting and malnutrition are common and serious complications in patients on hemodialysis and are strongly associated with adverse outcomes. Techniques for assessing nutrition have limitations and, due to metabolic effects and confounding effects of altered hydration and other body composition abnormalities, these limitations are greater in the context of renal failure. Bioelectrical impedance analysis is a promising method for the objective assessment and monitoring of body composition. Body composition techniques subdivide the body into compartments on the basis of differing physical properties. The different compartments reflect hydration, nutrition/wasting, body fat, and bone mineral content, which are all of great importance in patients on hemodialysis. We will conduct a prospective long-term follow up of HD patients' outcome correlates with nutritional status and body compositions. The patients will receive BIA every three months, and other routine clinical data such as dialysis adequacy and monthly biochemical data are collected to analyze. An additional blood sample of 8 ml will be collected every 3 months during the BIA survey for other inflammatory cytokines and nutritional markers such as adiponectin, leptin, ghrelin, prealbumin, fetuin A, fructosamine, IL-1, IL-6 and transferrin. The follow up period will be as long as possible and the last recruited into this study is in the Dec. 2016. These data will be used for the morbidity and mortality analysis to see if body compositions will be more useful and timely than the other nutritional parameters.

Conditions

Timeline

Start date
2012-03-01
Primary completion
2016-12-01
Completion
2016-12-01
First posted
2013-09-18
Last updated
2014-04-14

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT01945320. Inclusion in this directory is not an endorsement.