Body Composition Monitor(BCM) Guided Fluid Management in Maintenance Hemodialysis (MHD) Patients (BOCOMO)

Peking University

Status: Completed

Conditions: End Stage Renal Disease

Treatments: Device: Device; Device: body bioimpedance spectroscopy device

Study type: Interventional

Funder types: Other

Identifiers

NCT01509937

BOCOMO525

Details and patient eligibility

About

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.

Enrollment: 433 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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433 participants in 2 patient groups

BCM Arm

Experimental group

Description:

BCM measured every 2 months

Treatment:

Device: body bioimpedance spectroscopy device

Control arm

Sham Comparator group

Description:

patients care according to standard of care

Treatment:

Device: Device