The Effects Nutrition Status and Body Composition On Peritoneal Dialysis Outcome
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| First Received Date ICMJE | October 5, 2009 | ||||
| Last Updated Date | November 15, 2012 | ||||
| Start Date ICMJE | December 2011 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Measure BCM could be a nutrition status marker [ Time Frame: 5 yrs ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00990171 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effects Nutrition Status and Body Composition On Peritoneal Dialysis Outcome | ||||
| Official Title ICMJE | The Effects Nutrition Status and Body Composition On Peritoneal Dialysis | ||||
| Brief Summary | A prospective long-term follow up of peritoneal dialysis patients' outcome correlates with nutritional status and body composition. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: plasma dianeal |
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| Sampling Method | Probability Sample | ||||
| Study Population | PD patients |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | PD-BCM
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 300 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00990171 | ||||
| Other Study ID Numbers ICMJE | 200906084R | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | National Taiwan University Hospital | ||||
| Study Sponsor ICMJE | National Taiwan University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | National Taiwan University Hospital | ||||
| Verification Date | August 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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