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The Effects Nutrition Status and Body Composition On Peritoneal Dialysis Outcome

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ClinicalTrials.gov Identifier: NCT00990171
Recruitment Status : Unknown
Verified April 2014 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : October 6, 2009
Last Update Posted : April 14, 2014
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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

Condition or disease
Peritoneal Dialysis Wasting and Malnutrition

Detailed Description:
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.

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effects Nutrition Status and Body Composition On Peritoneal Dialysis Outcome
Study Start Date : December 2011
Estimated Primary Completion Date : December 2016

Group/Cohort
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



Primary Outcome Measures :
  1. Measure BCM could be a nutrition status marker [ Time Frame: 5 yrs ]

Biospecimen Retention:   Samples Without DNA
plasma dianeal


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
PD patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00990171


Contacts
Contact: Jenq-Wen Huang, MD +886-2-23123456 ext 63288 007378@ntuh.gov.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact: Jenq-Wen Huang, MD    +886-2-23123456 ext 63288    007378@ntuh.gov.tw   
Sponsors and Collaborators
National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00990171     History of Changes
Other Study ID Numbers: 200906084R
First Posted: October 6, 2009    Key Record Dates
Last Update Posted: April 14, 2014
Last Verified: April 2014

Keywords provided by National Taiwan University Hospital:
peritoneal Dialysis
wasting and malnutrition
nutrition status
bioelectrical impedance analysis
body composition

Additional relevant MeSH terms:
Malnutrition
Cachexia
Wasting Syndrome
Nutrition Disorders
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases