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

November 22, 2015 updated by: Li Zuo, Peking University First Hospital

A Randomized Controlled Trial of Long Term Effect of BCM Guided Fluid Management in MHD Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

433

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Institute of Nephrology, Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Device: Device
participants in control arm will not receive BCM measurement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
during 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Left ventricular thickness once a year
Time Frame: baseline, and once a year during the following 36 months
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
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.
Baseline, and every 2 months during the following 36 months
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.
during the 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Collaborators

Fresenius Medical Care (Shanghai) Co., Ltd

Investigators

  • Study Director: Li Zuo, MD & PhD, Institute of Nephrology, Peking University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

January 3, 2012

First Submitted That Met QC Criteria

January 12, 2012

First Posted (ESTIMATE)

January 13, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 24, 2015

Last Update Submitted That Met QC Criteria

November 22, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BOCOMO525

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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