Body Composition Monitor in Hemodialysis Patients

The Association Between Body Composition and Biomarkers in Hemodialysis Patients

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01103167

Enrollment

160

Registered

2010-04-14

Start date

2010-04-30

Completion date

2010-12-31

Last updated

2010-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease

Keywords

body composition, blood pressure, hemodialysis

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.

Interventions

BEHAVIORALcontrol of ultrafiltration

During the interventional period, dry weight of patients will be adjusted according to the results of body composition.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
blood pressure	up to 16 weeks	Systolic blood pressure, number of anti-hypertensive agents hypotensive episode

Secondary

Measure	Time frame	Description
biomarkers	up to 16 weeks	C-reactive protein, interleukin-6, MMP-1, leptin, resistin, adiponectin, VEGF

Countries

South Korea

Contacts

Primary ContactSejoong Kim, MD, PhD

imsejoong@hanmail.net82-32-460-8305

Backup ContactKwon Wook Joo, MD, PhD

junephro@paran.com82-2-2072-1964

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026