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The Effects Nutrition Status and Body Composition On Peritoneal Dialysis Outcome

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2014 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00990171
First Posted: October 6, 2009
Last Update Posted: April 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Taiwan University Hospital
October 5, 2009
October 6, 2009
April 14, 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 ]
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
Not Provided
Retention:   Samples Without DNA
Description:
plasma dianeal
Probability Sample
PD patients
  • Peritoneal Dialysis
  • Wasting and Malnutrition
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
300
Not Provided
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
Sexes Eligible for Study: All
20 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT00990171
200906084R
Yes
Not Provided
Not Provided
National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Not Provided
National Taiwan University Hospital
April 2014
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