Body Composition Monitor in Hemodialysis Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Gachon University Gil Medical Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Gachon University Gil Medical Center
Collaborators:
Seoul National University Hospital
Seoul National University Bundang Hospital
Information provided by:
Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT01103167
First received: April 9, 2010
Last updated: April 13, 2010
Last verified: April 2010
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | April 9, 2010 | ||||||||
| Last Updated Date | April 13, 2010 | ||||||||
| Start Date ICMJE | April 2010 | ||||||||
| Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
blood pressure [ Time Frame: up to 16 weeks ] [ Designated as safety issue: Yes ] Systolic blood pressure, number of anti-hypertensive agents hypotensive episode |
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01103167 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
biomarkers [ Time Frame: up to 16 weeks ] [ Designated as safety issue: Yes ] C-reactive protein, interleukin-6, MMP-1, leptin, resistin, adiponectin, VEGF |
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Body Composition Monitor in Hemodialysis Patients | ||||||||
| Official Title ICMJE | The Association Between Body Composition and Biomarkers in Hemodialysis Patients | ||||||||
| 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. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||||||
| Condition ICMJE | End Stage Renal Disease | ||||||||
| Intervention ICMJE | Behavioral: control of ultrafiltration
During the interventional period, dry weight of patients will be adjusted according to the results of body composition. |
||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 160 | ||||||||
| Estimated Completion Date | December 2010 | ||||||||
| Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Korea, Republic of | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01103167 | ||||||||
| Other Study ID Numbers ICMJE | korea_bcm_hd | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Gachon University Gil Medical Center IRB, Gachon University Gil Medical Center | ||||||||
| Study Sponsor ICMJE | Gachon University Gil Medical Center | ||||||||
| Collaborators ICMJE |
|
||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Gachon University Gil Medical Center | ||||||||
| Verification Date | April 2010 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||