Body Composition Monitor in Hemodialysis Patients
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|ClinicalTrials.gov Identifier: NCT01103167|
Recruitment Status : Unknown
Verified April 2010 by Gachon University Gil Medical Center.
Recruitment status was: Recruiting
First Posted : April 14, 2010
Last Update Posted : April 14, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease||Behavioral: control of ultrafiltration||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Association Between Body Composition and Biomarkers in Hemodialysis Patients|
|Study Start Date :||April 2010|
|Estimated Primary Completion Date :||October 2010|
|Estimated Study Completion Date :||December 2010|
- Behavioral: control of ultrafiltration
During the interventional period, dry weight of patients will be adjusted according to the results of body composition.
- blood pressure [ Time Frame: up to 16 weeks ]Systolic blood pressure, number of anti-hypertensive agents hypotensive episode
- biomarkers [ Time Frame: up to 16 weeks ]C-reactive protein, interleukin-6, MMP-1, leptin, resistin, adiponectin, VEGF
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|