Status:
COMPLETED
Body Composition Monitor(BCM) Guided Fluid Management in Maintenance Hemodialysis (MHD) Patients
Lead Sponsor:
Peking University First Hospital
Collaborating Sponsors:
Fresenius Medical Care (Shanghai) Co., Ltd
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
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 helpfu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
433 Patients enrolled
Trial Details
Trial ID
NCT01509937
Start Date
January 1 2013
End Date
June 1 2015
Last Update
November 24 2015
Active Locations (1)
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1
Institute of Nephrology, Peking University First Hospital
Beijing, Beijing Municipality, China, 100034