NCT01945320

Brief Summary

A prospective long-term follow up of hemodialysis (HD) patients' outcome correlates with nutritional status and body composition. We will evaluate the body composition change among HD patients every three months with bioelectrical impedance analysis (BIA). The change of body composition will correlated with other clinical data including nutritional, inflammatory parameters and survival.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 18, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 14, 2014

Status Verified

April 1, 2014

Enrollment Period

4.8 years

First QC Date

September 9, 2013

Last Update Submit

April 11, 2014

Conditions

Body CompositionNutritional WastingMalnutrition

Keywords

hemodialysiswasting and malnutritionnutrition statusbioelectrical impedance analysisbody composition

Outcome Measures

Primary Outcomes (1)

  • To evaluate the correlation between the change of body composition by bioelectrical impedance analysis (BIA) with other clinical data including nutritional, inflammatory parameters and survival.

    Participants will be tracked once every 6 months, up to 5 years to be followed.

Study Arms (1)

HD-BCM

1. Patients at National Taiwan University Hospital 2. Patients who have received HD more than 3 months 3. Patients who sign the informed consents 4. Patients who aged between 20-90 years

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

HD patients

You may qualify if:

  • Patients at National Taiwan University Hospital
  • Patients who have received hemodialysis more than 3 months
  • Patients who sign the informed consents

You may not qualify if:

  • Patients who have received hemodialysis less than 3 months
  • Patients who refuse to sign informed consents
  • Patients who refuse to draw additional blood for research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 10002, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

MalnutritionCachexia

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesWeight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinness

Central Study Contacts

Jenq-Wen Huang, Doctor

CONTACT

+886-2-2312-3456007378@ntuh.gov.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2013

First Posted

September 18, 2013

Study Start

March 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 14, 2014

Record last verified: 2014-04

Locations

TW(1)