Volume Status Clinical Trial
Official title:
Bioimpedance Versus Clinical Methods in Guiding Ultrafiltration in Hemodialysis Patients: a Randomized Trial
The investigators developed a prospective, randomized, controlled trial to compare strict volume control using bioimpedance (using the BCM - Body Composition Monitor device) versus traditional clinical volume control in hemodialysis patients and the impact on mortality, hydration status, blood pressure values and arterial stiffness.
The investigators developed a randomized controlled study to compare exclusively
bioimpedance guided ultrafiltration in hemodialysis patients versus traditional methods for
volume assessment.
The duration of the study was 3,5 years.
During the first 2,5 years of the study all enrolled patients were randomized using a block
randomization algorithm in two arms.
In the interventional arm the post-dialysis dry weight was prescribed exclusively using the
BCM device (Body Composition Monitor - Fresenius Medical Care, Germany).
In the control arm dry weight assessment was done by traditional clinical methods.
In both arms,during the intervention period (2,5 years) BCM measurements were performed
every 3 months before dialysis, but only in the interventional arm the values were disclosed
to the medical personnel and used to guide the dry weight and ultrafiltration volumes.
In the control arm (clinical), both patients and caregivers were fully blinded from the BCM
results.
The BCM device measures for each patient an ideal dry weight interval ( +/- 1.1 kg). In the
interventional arm, the prescribed dry weights of the patients were strictly maintained in
the ideal weight interval (+/- 1.1 kg) proposed by the BCM device.
Primary outcome was all cause-mortality compared in the strict bioimpedance arm versus the
clinical (control) arm and was assessed at 2,5 years.
Secondary end-points, assessed during the randomization period (2,5 years), were to compare
blood pressure (determined pre dialysis), arterial stiffness and relative fluid overload
(RFO = overhydration/ total body water), as measured by the BCM device.
During the last year of the study, all patients were left free of any intervention, and only
arterial stiffness was assessed a third time at 3,5 years.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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