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

This study is not yet open for participant recruitment.
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
History of Changes
  Purpose

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.


Condition Intervention
End Stage Renal Disease
 Device: body bioimpedance spectroscopy device
Device: Device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial of Long Term Effect of BCM Guided Fluid Management in MHD Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Peking University First Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 1354
Study Start Date: October 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509937

Contacts
Contact: Li Zuo, MD & PhD 86 10 83575740 zuolimd@gmail.com

Locations
China, Beijing
Institute of Nephrology, Peking University First Hospital Not yet recruiting
Beijing, Beijing, China, 100034
Contact: Li Zuo, MD & PhD     86 10 83575740     zuolimd@gmail.com    
Contact: Xuyang Cheng, MD & PhD     80 10 83573060     chengxuyang@medmail.com.cn    
Principal Investigator: Li Zuo, MD & PhD            
Sub-Investigator: Xuyang Cheng, MD & PhD            
Sub-Investigator: Li Liu, MD & PhD            
Sponsors and Collaborators
Peking University First Hospital
Fresenius Medical Care Shanghai, China
Investigators
Study Director: Li Zuo, MD & PhD Institute of Nephrology, Peking University
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Li Zuo, Clinical professor, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT01509937     History of Changes
Other Study ID Numbers: BOCOMO525
Study First Received: January 3, 2012
Last Updated: September 11, 2012
Health Authority: China: Ethics Committee

Keywords provided by Peking University First Hospital:
end stage renal disease
maintenance hemodialysis
dry weight
bioimpedance spectroscopy analysis
 body composition monitor
Fresenius BCM
Ultrafiltration

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on May 23, 2013