Body Composition Monitor(BCM) Guided Fluid Management in Maintenance Hemodialysis (MHD) Patients
NCT ID: NCT01509937
Last Updated: 2015-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
433 participants
INTERVENTIONAL
2013-01-31
2015-06-30
Brief Summary
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Background: Bioimpedance analysis (BIA) was helpful in identifying hypervolemia. Observational data using BIA methods showed that hypervolemic patients on maintenance hemodialysis (MHD) suffered from high mortality risk. But it is not clear if BIA guided fluid management can improve MHD patients' survival. The objectives of the BOCOMO study are to evaluate the outcome of BIA guided fluid management comparing with standard care.
Design: This is a multicenter, prospective, randomized, controlled trial. Setting and Participants: More than 1300 participants from 16 clinical sites will be included in the study. The enrollment period will last 6 months, and minimum length of follow-up will not less than 36 months. MHD patients aged more than 18 years but less than 80 years who had been on MHD for at least 3 months and considered suitable candidates will be invited to participate in the study. Participants will be randomized to BIA arm or control arm using 1:1 ratio. A portable whole body bioimpedance spectroscopy device (BCM-Fresenius Medical Care D GmbH) will be used for BIA measurement at baseline for both arm, and every 2 months in BCM arm.
Predictors: BCM guided fluid management and fluid management using standard care.
Outcome and measurements: The primary intent-to-treat analysis compares composite endpoint between BCM arm and control arm. The secondary intent-to-treat analysis compares left ventricular thickness, blood pressure, medication, and incidence and length of hospitalization between BCM arm and control arm. Death, acute myocardial infarction, stroke, peripheral arterial disease will be used as composite endpoint.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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BCM Arm
BCM measured every 2 months
body bioimpedance spectroscopy device
Name of the device is BCM from Fresenius Medical Care D GmbH
Control arm
patients care according to standard of care
Device
participants in control arm will not receive BCM measurement.
Interventions
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body bioimpedance spectroscopy device
Name of the device is BCM from Fresenius Medical Care D GmbH
Device
participants in control arm will not receive BCM measurement.
Eligibility Criteria
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Inclusion Criteria
* age of 18 years or older but 80 years or less
* on MHD for at least 3 months
* dialysis frequency of at least 5 sessions per 2 weeks, not less than 4 hours per session, Kt/V at least 1.2
* urine volume less than 800mL per 24 hours the day before dialysis session,
* bioimpedance analysis not used within recent 3 months
* dry weight regarded as adequate according to the patient's responsible doctor
* the ability to understand and willingness to sign an informed consent statement.
Exclusion Criteria
* active rheumatic disease, or current on cortical steroid medication or cytotoxic medication
* uncontrolled neoplasm
* acute myocardial infarction within 1 month
* congestive heart failure (NYHA 3 - 4)
* stroke within 3 months,
* metallic installation, like contraceptive device, artificial joint(s)
* amputation
* female of childbearing age who has a pregnancy plan, or is pregnant, or on breast feeding
* having a plan to reduce dialysis frequency
* having a renal transplantation plan or planning to transfer to peritoneal dialysis within 3 years
* participating or planning to participate another clinical trial, which will confound the current study
18 Years
80 Years
ALL
No
Sponsors
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Fresenius Medical Care (Shanghai) Co., Ltd
UNKNOWN
Peking University First Hospital
OTHER
Responsible Party
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Li Zuo
Clinical professor
Principal Investigators
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Li Zuo, MD & PhD
Role: STUDY_DIRECTOR
Institute of Nephrology, Peking University
Locations
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Institute of Nephrology, Peking University First Hospital
Beijing, Beijing Municipality, China
Countries
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References
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Lintsi M, Kaarma H, Kull I. Comparison of hand-to-hand bioimpedance and anthropometry equations versus dual-energy X-ray absorptiometry for the assessment of body fat percentage in 17-18-year-old conscripts. Clin Physiol Funct Imaging. 2004 Mar;24(2):85-90. doi: 10.1111/j.1475-097X.2004.00534.x.
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Liu L, Sun Y, Chen Y, Xu J, Yuan P, Shen Y, Lin S, Sun W, Ma Y, Ren J, Liu W, Lei J, Zuo L. The effect of BCM guided dry weight assessment on short-term survival in Chinese hemodialysis patients : Primary results of a randomized trial - BOdy COmposition MOnitor (BOCOMO) study. BMC Nephrol. 2020 Apr 15;21(1):135. doi: 10.1186/s12882-020-01793-x.
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Other Identifiers
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BOCOMO525
Identifier Type: -
Identifier Source: org_study_id