Clinical trial NCT01945320: The Effects Nutrition Status and Body Composition on HD Patients' Outcome
Official title: The Effects Nutrition Status and Body Composition on HD Patients' Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Body Composition
Nutritional Wasting
Malnutrition
Keywords: hemodialysis
wasting and malnutrition
nutrition status
bioelectrical impedance analysis
body composition
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-09-18
Enrollment: 250
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HD patients

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients at National Taiwan University Hospital
* Patients who have received hemodialysis more than 3 months
* Patients who sign the informed consents

Exclusion Criteria:

* Patients who have received hemodialysis less than 3 months
* Patients who refuse to sign informed consents
* Patients who refuse to draw additional blood for research

Primary outcomes:
measure: To evaluate the correlation between the change of body composition by bioelectrical impedance analysis (BIA) with other clinical data including nutritional, inflammatory parameters and survival.
timeFrame: Participants will be tracked once every 6 months, up to 5 years to be followed.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: