Clinical trial NCT01509937: Body Composition Monitor(BCM) Guided Fluid Management in Maintenance Hemodialysis (MHD) Patients
Official title: A Randomized Controlled Trial of Long Term Effect of BCM Guided Fluid Management in MHD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Keywords: end stage renal disease
maintenance hemodialysis
dry weight
bioimpedance spectroscopy analysis
body composition monitor
Fresenius BCM
Ultrafiltration
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Fresenius Medical Care (Shanghai) Co., Ltd
First posted: 2012-01-13
Enrollment: 433
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* diagnosis of end stage renal disease (ESRD) and need MHD
* 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:

* acute infection within 1 month
* 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

Primary outcomes:
measure: Incidence of composite endpoint
timeFrame: during 36 months
Secondary outcomes:
measure: Change from baseline in Left ventricular thickness once a year
timeFrame: baseline, and once a year during the following 36 months
measure: Change from baseline in Pre-dialysis blood pressure every 2 months
timeFrame: baseline, every 2 months during the following 36 months
measure: Change from baseline in anti-hypertensives DDD every 2 months
timeFrame: Baseline, and every 2 months during the following 36 months
measure: Incidence of all cause and congestive heart failure related hospitalization
timeFrame: during the 36 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Nephrology, Peking University First Hospital
state: Beijing
Study officials:
affiliation: Institute of Nephrology, Peking University
name: Li Zuo, MD & PhD
role: STUDY_DIRECTOR
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