Body Composition Monitor(BCM) Guided Fluid Management in Maintenance Hemodialysis (MHD) Patients (BOCOMO)
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|ClinicalTrials.gov Identifier: NCT01509937|
Recruitment Status : Completed
First Posted : January 13, 2012
Last Update Posted : November 24, 2015
It is hypothesized that bioimpedance spectroscope guided fluid management will help patient reach euvolemic status, and increase long term survival.
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.
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease||Device: body bioimpedance spectroscopy device Device: Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||433 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomized Controlled Trial of Long Term Effect of BCM Guided Fluid Management in MHD Patients|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Experimental: BCM Arm
BCM measured every 2 months
Device: body bioimpedance spectroscopy device
Name of the device is BCM from Fresenius Medical Care D GmbH
Sham Comparator: Control arm
patients care according to standard of care
participants in control arm will not receive BCM measurement.
- Incidence of composite endpoint [ Time Frame: during 36 months ]Death, acute myocardial infarction, cerebral thrombosis, cerebral hemorrhage, peripheral arterial disease will be used as composite endpoint.
- Change from baseline in Left ventricular thickness once a year [ Time Frame: baseline, and once a year during the following 36 months ]
- Change from baseline in Pre-dialysis blood pressure every 2 months [ Time Frame: baseline, every 2 months during the following 36 months ]
- Change from baseline in anti-hypertensives DDD every 2 months [ Time Frame: Baseline, and every 2 months during the following 36 months ]Defined daily dose (DDD) will be calculated according to WHO recommendation at baseline, and every 2 months thereafter. Trend of DDD change will be compared between the two arms.
- Incidence of all cause and congestive heart failure related hospitalization [ Time Frame: during the 36 months ]Incidence of all cause and congestive heart failure related hospitalization will be compared between arms.
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): NCT01509937
|Institute of Nephrology, Peking University First Hospital|
|Beijing, Beijing, China, 100034|
|Study Director:||Li Zuo, MD & PhD||Institute of Nephrology, Peking University|