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NCT Number: NCT01509937

Body Composition Monitor(BCM) Guided Fluid Management in Maintenance Hemodialysis (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.

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Nephrology, Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

body bioimpedance spectroscopy device

Device

Name of the device is BCM from Fresenius Medical Care D GmbH

Device

Device

participants in control arm will not receive BCM measurement.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change from baseline in Left ventricular thickness once a year

    Time frame: baseline, and once a year during the following 36 months

  2. Change from baseline in Pre-dialysis blood pressure every 2 months

    Time frame: baseline, every 2 months during the following 36 months

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

  • Fresenius Medical Care (Shanghai) Co., Ltd

Registry information

Official study title

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

Acronym: BOCOMO

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 13, 2012
Registry last updated
Nov 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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