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

NCT01509937 | Completed DMC

• 1 other identifier: BOCOMO525
• Study Type: interventional
• Target: 433
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End Stage Renal Disease

Keywords

end stage renal disease; maintenance hemodialysis; dry weight; bioimpedance spectroscopy analysis; body composition monitor; Fresenius BCM; Ultrafiltration

Outcome Measures

Primary Outcomes (1)

• Incidence of composite endpoint

  Death, acute myocardial infarction, cerebral thrombosis, cerebral hemorrhage, peripheral arterial disease will be used as composite endpoint.

  during 36 months

Secondary Outcomes (4)

• Change from baseline in Left ventricular thickness once a year

  baseline, and once a year during the following 36 months

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

  baseline, every 2 months during the following 36 months

• Change from baseline in anti-hypertensives DDD every 2 months

  Baseline, and every 2 months during the following 36 months

• Incidence of all cause and congestive heart failure related hospitalization

  during the 36 months

Study Arms (2)

BCM Arm

EXPERIMENTAL

BCM measured every 2 months

Device: body bioimpedance spectroscopy device

Control arm

SHAM COMPARATOR

patients care according to standard of care

Device: Device

Interventions

body bioimpedance spectroscopy device DEVICE

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

BCM Arm

Device DEVICE

participants in control arm will not receive BCM measurement.

Control arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University First Hospital: lead
• Fresenius Medical Care (Shanghai) Co., Ltd: collaborator

Study Sites (1)

Institute of Nephrology, Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (22)

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• Liu L, Sun Y, Chen Y, Xu J, Yuan P, Shen Y, Lin S, Sun W, Ma Y, Ren J, Liu W, Lei J, Zuo L. The effect of BCM guided dry weight assessment on short-term survival in Chinese hemodialysis patients : Primary results of a randomized trial - BOdy COmposition MOnitor (BOCOMO) study. BMC Nephrol. 2020 Apr 15;21(1):135. doi: 10.1186/s12882-020-01793-x.

  PMID: 32295531 DERIVED

• Liu L, Long G, Ren J, Li J, Xu J, Lei J, Li M, Qiu M, Yuan P, Sun W, Lin S, Liu W, Sun Y, Ma Y, Mao Y, Shen Y, Zuo L. A randomized controlled trial of long term effect of BCM guided fluid management in MHD patients (BOCOMO study): rationales and study design. BMC Nephrol. 2012 Sep 25;13:120. doi: 10.1186/1471-2369-13-120.

  PMID: 23006960 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

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

Study Officials

• Li Zuo, MD & PhD

  Institute of Nephrology, Peking University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: January 3, 2012
• First Posted: January 13, 2012
• Study Start: January 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 24, 2015

Record last verified: 2015-11

Locations

CN (1)