NCT01509937

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 433 (actual)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2012-01-13
• Last updated: 2015-11-24

Locations

1 site across 1 country: China