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
  Purpose

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


Condition
Peritoneal Dialysis
Wasting and Malnutrition

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effects Nutrition Status and Body Composition On Peritoneal Dialysis Outcome

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Measure BCM could be a nutrition status marker [ Time Frame: 5 yrs ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

plasma dianeal


Estimated Enrollment: 300
Study Start Date: December 2011
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00990171     History of Changes
Other Study ID Numbers: 200906084R
Study First Received: October 5, 2009
Last Updated: April 11, 2014
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on October 21, 2014