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

Study Overview
=================
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.

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

Conditions
-----------------
End Stage Renal Disease

Intervention / Treatment
-----------------
* Device: body bioimpedance spectroscopy device
* Device: Device


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BCM Arm<br>BCM measured every 2 months | Device: body bioimpedance spectroscopy device<br>* Name of the device is BCM from Fresenius Medical Care D GmbH<br>|
| Sham Comparator: Control arm<br>patients care according to standard of care | Device: Device<br>* participants in control arm will not receive BCM measurement.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Incidence of all cause and congestive heart failure related hospitalization will be compared between arms. | during the 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
end stage renal disease, maintenance hemodialysis, dry weight, bioimpedance spectroscopy analysis, body composition monitor, Fresenius BCM, Ultrafiltration