Status:
COMPLETED
Effects Of Volume Control Guided by Body Composition Monitor (BCM) on Blood Pressure and Cardiac Condition in Hemodialysis Patients
Lead Sponsor:
Ege University
Collaborating Sponsors:
Fresenius Medical Care North America
Conditions:
Left Ventricular Hypertrophy
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This prospective, randomized, controlled study aims to evaluate the usefulness of the new body composition monitor (BCM) device as a method to improve volume control in hemodialysis (HD) patients and ...
Detailed Description
The proposed prospective, randomized, controlled study intends to document the effect of volume control guided by BCM on blood pressure (determined both manually and 48-h ambulatory), need for anti-hy...
Eligibility Criteria
Inclusion
- Age older than 18-year,
- Maintenance bicarbonate HD scheduled thrice weekly (12 hours/week),
- Willingness to participate in the study with a written informed consent.
Exclusion
- Presence of a cardiac stent, pacemaker or defibrillator ,
- Artificial joints, pin or amputation
- Permanent or temporary catheters (may affect BCM measurement),
- Being scheduled for living donor renal transplantation,
- Presence of serious life-limiting co-morbid situations, like malignancy, uncontrollable infection, end-stage cardiac, pulmonary, or hepatic disease,
- Pregnancy or lactating,
- Current use of investigational drugs or participation in an interventional clinical trial that contradicts or interferes with the therapies or measured outcomes in this trial,
- Mental incompetence.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00974857
Start Date
June 1 2009
End Date
September 1 2010
Last Update
September 9 2013
Active Locations (1)
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1
Ege University Division of Nephrology
Bornova, İzmir, Turkey (Türkiye), 35100