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Clinical Trials/NCT01103167
NCT01103167
Unknown
Phase 4

The Association Between Body Composition and Biomarkers in Hemodialysis Patients

Gachon University Gil Medical Center1 site in 1 country160 target enrollmentApril 2010

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
End Stage Renal Disease
Sponsor
Gachon University Gil Medical Center
Enrollment
160
Locations
1
Primary Endpoint
blood pressure
Last Updated
16 years ago

Overview

Brief Summary

Control of volume status is a pivotal issue in haemodialysis therapy. Objective and practical management for maintaining normovolemia is needed.

The investigators hypothesized that intervention of volume status with the body composition monitor (BCM) may improved hemodynamic parameters and biomarkers in hemodialysis patients.

Detailed Description

The investigators will assess BCM in enrolled hemodialysis patients by 4 weeks for 16 weeks During the former 8-week intervention period, The investigators will adjust patients' volume status according to the results of BCM. During the latter 8-week observational period, The investigators will evaluate the changes of patients' hemodynamic parameters and biomarkers.

Registry
clinicaltrials.gov
Start Date
April 2010
End Date
December 2010
Last Updated
16 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 6-month or more stable hemodialysis patients
  • 18 years or more
  • less than 5% of changes of dry weight for last 3 months

Exclusion Criteria

  • pregnancy
  • active malignancy
  • cardiac pacemaker or defibrillator
  • history of extremity amputation
  • active infectious disease within 3 months
  • admission history for complication related to hemodialysis within 3 months

Outcomes

Primary Outcomes

blood pressure

Time Frame: up to 16 weeks

Systolic blood pressure, number of anti-hypertensive agents hypotensive episode

Secondary Outcomes

  • biomarkers(up to 16 weeks)

Study Sites (1)

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