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The Effects Nutrition Status and Body Composition On Peritoneal Dialysis Outcome

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00990171
First received: October 5, 2009
Last updated: April 11, 2014
Last verified: April 2014

October 5, 2009
April 11, 2014
December 2011
December 2016   (final data collection date for primary outcome measure)
Measure BCM could be a nutrition status marker [ Time Frame: 5 yrs ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00990171 on ClinicalTrials.gov Archive Site
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The Effects Nutrition Status and Body Composition On Peritoneal Dialysis Outcome
The Effects Nutrition Status and Body Composition On Peritoneal Dialysis Outcome

A prospective long-term follow up of peritoneal dialysis patients' outcome correlates with nutritional status and body composition.

Wasting and malnutrition are common and serious complications in patients on peritoneal dialysis 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 peritoneal dialysis. We will conduct a prospective long-term follow up of PD 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, peritoneal equilibration test and monthly biochemical data are collected to analyze. An additional blood sample 8 ml and 5 ml dialysate of overnight, 0 hour, 2 hour and 4 hour will be collected during annual PET for other inflammatory cytokines and nutritional markers such as adiponectin, leptin, ghrelin, prealbumin and transferrin. The follow up period will be as long as possible and the last recruited into this study is in the Aug 2014. 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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

plasma dianeal

Probability Sample

PD patients

  • Peritoneal Dialysis
  • Wasting and Malnutrition
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PD-BCM
  1. Patients at National Taiwan University Hospital (NTUH)
  2. Patients who have received PD more than 3 months
  3. Patients who sign the informed consents
  4. Patients who aged between 20-90 years
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
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December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients at National Taiwan University Hospital
  2. Patients who have received PD more than 3 months
  3. Patients who sign the informed consents

Exclusion Criteria:

  1. Patients who have received PD less than 3 months
  2. Patients who refuse to sign informed consents
  3. Patients who refuse to draw additional blood for research
Both
20 Years to 90 Years
No
Contact: Jenq-Wen Huang, MD +886-2-23123456 ext 63288 007378@ntuh.gov.tw
Taiwan
 
NCT00990171
200906084R
Yes
National Taiwan University Hospital
National Taiwan University Hospital
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Not Provided
National Taiwan University Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP