Body Composition Monitor in Hemodialysis Patients
Recruitment status was Recruiting
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Association Between Body Composition and Biomarkers in Hemodialysis Patients|
- blood pressure [ Time Frame: up to 16 weeks ] [ Designated as safety issue: Yes ]Systolic blood pressure, number of anti-hypertensive agents hypotensive episode
- biomarkers [ Time Frame: up to 16 weeks ] [ Designated as safety issue: Yes ]C-reactive protein, interleukin-6, MMP-1, leptin, resistin, adiponectin, VEGF
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Behavioral: control of ultrafiltration
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103167
|Contact: Sejoong Kim, MD, PhDfirstname.lastname@example.org|
|Contact: Kwon Wook Joo, MD, PhDemail@example.com|
|Korea, Republic of|
|Incheon, Korea, Republic of, 405-760|
|Contact: Sejoong Kim, MD, PhD 82-32-460-8305 firstname.lastname@example.org|
|Contact: Kwon Wook Joo, MD, PhD 82-2-2072-1964 email@example.com|
|Sub-Investigator: Kwon Wook Joo, MD, PhD|
|Sub-Investigator: Ho Jun Chin, MD, PhD|
|Principal Investigator:||Sejoong Kim, MD, PhD||Gachon University Gil Medical Center|