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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2012 by Peking University First Hospital
Sponsor:
Collaborator:
Fresenius Medical Care Shanghai, China
Information provided by (Responsible Party):
Li Zuo, Peking University First Hospital
ClinicalTrials.gov Identifier:
NCT01509937
First received: January 3, 2012
Last updated: September 11, 2012
Last verified: September 2012

January 3, 2012
September 11, 2012
October 2012
April 2016   (final data collection date for primary outcome measure)
Incidence of composite endpoint [ Time Frame: during 36 months ] [ Designated as safety issue: No ]
Death, acute myocardial infarction, cerebral thrombosis, cerebral hemorrhage, peripheral arterial disease will be used as composite endpoint.
Incidence of composite endpoint [ Time Frame: during 30 months ] [ Designated as safety issue: No ]
Death, acute myocardial infarction, cerebral thrombosis, cerebral hemorrhage, peripheral arterial disease will be used as composite endpoint.
Complete list of historical versions of study NCT01509937 on ClinicalTrials.gov Archive Site
  • Change from baseline in Left ventricular thickness once a year [ Time Frame: baseline, and once a year during the following 36 months ] [ Designated as safety issue: No ]
  • Change from baseline in Pre-dialysis blood pressure every 2 months [ Time Frame: baseline, every 2 months during the following 36 months ] [ Designated as safety issue: No ]
  • Change from baseline in anti-hypertensives DDD every 2 months [ Time Frame: Baseline, and every 2 months during the following 36 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Incidence of all cause and congestive heart failure related hospitalization will be compared between arms.
  • Change from baseline in Left ventricular thickness once a year [ Time Frame: baseline, and once a year during the following 30 months ] [ Designated as safety issue: No ]
  • Change from baseline in Pre-dialysis blood pressure every 2 months [ Time Frame: baseline, every 2 months during the following 30 months ] [ Designated as safety issue: No ]
  • Change from baseline in anti-hypertensives DDD every 2 months [ Time Frame: Baseline, and every 2 months during the following 30 months ] [ Designated as safety issue: No ]
    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 30 months ] [ Designated as safety issue: No ]
    Incidence of all cause and congestive heart failure related hospitalization will be compared between arms.
Not Provided
Not Provided
 
Body Composition Monitor(BCM) Guided Fluid Management in Maintenance Hemodialysis (MHD) Patients
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
End Stage Renal Disease
  • Device: body bioimpedance spectroscopy device
    Name of the device is BCM from Fresenius Medical Care D GmbH
  • Device: Device
    participants in control arm will not receive BCM measurement.
  • Experimental: BCM Arm
    BCM measured every 2 months
    Intervention: Device: body bioimpedance spectroscopy device
  • Sham Comparator: Control arm
    patients care according to standard of care
    Intervention: Device: Device

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
1354
April 2016
April 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Li Zuo, MD & PhD 86 10 83575740 zuolimd@gmail.com
China
 
NCT01509937
BOCOMO525
Yes
Li Zuo, Peking University First Hospital
Peking University First Hospital
Fresenius Medical Care Shanghai, China
Study Director: Li Zuo, MD & PhD Institute of Nephrology, Peking University
Peking University First Hospital
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP