Body Composition Monitor in Hemodialysis Patients

End Stage Renal Disease Clinical Trial

Official title:

The Association Between Body Composition and Biomarkers in Hemodialysis Patients

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01103167
• Other study ID #: korea_bcm_hd
• Status: Unknown status
• Phase: Phase 4
• First received: April 9, 2010
• Last updated: April 13, 2010
• Start date: April 2010
• Est. completion date: December 2010

Study information

• Verified date: April 2010
• Source: Gachon University Gil Medical Center
• Contact: Sejoong Kim, MD, PhD
• Phone: 82-32-460-8305
• Email: imsejoong[@]hanmail.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 160
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Behavioral:
• control of ultrafiltration
During the interventional period, dry weight of patients will be adjusted according to the results of body composition.

Locations

Country	Name	City	State
Korea, Republic of	Sejoong Kim	Incheon

Sponsors (3)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center	Seoul National University Bundang Hospital, Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood pressure	Systolic blood pressure, number of anti-hypertensive agents hypotensive episode	up to 16 weeks
Secondary	biomarkers	C-reactive protein, interleukin-6, MMP-1, leptin, resistin, adiponectin, VEGF	up to 16 weeks