Fluid Shifts Clinical Trial
Official title:
Body Composition Monitoring for Determination of the Fluid Status in Volunteers Undergoing Intravenous Fluid Therapy
This volunteer study tests a recently developed whole-body bioimpedance spectroscopy device
called Body Composition Monitor (BCM) which measures the body composition (i.e. the water
content of the body).
Specifically, the investigators will evaluate the use of BCM for correct detection of
intravenous administered crystalloids in the volunteers´ fluid compartments. Furthermore we
will test the change over time of the volunteers´ volume status after an intravenous fluid
therapy.
Technically assisted assessment of volume status may be useful to direct fluid
administration.
As a prerequisite the investigators will test a recently developed whole-body bioimpedance
spectroscopy device to determine fluid status in volunteers after an intravenous fluid
therapy.
The correlation of infused fluid and change of the fluid status measured with Body
Composition Monitor (BCM, Fresenius Medical Care, Germany) is still unknown.
Using a three-compartment physiologic tissue model, BCM determine total body fluid volume
(TBV), extracellular volume (ECV), intracellular volume (ICV) and fluid overload (FO) as
surplus or deficit of 'normal' extracellular volume. The BCM device measures resistance and
reactance at 50 discrete frequencies covering the frequency spectrum from 5 to 1000 kHz
through the entire patient via 4 electrodes placed on the wrist and ankle.
Fifteen volunteers will be enrolled in a randomized, blinded cross over study. After
randomisation into one of two treatments the volunteer will receive either an iv isotonic
fluid therapy of Elo-mel® (Fresenius Kabi Austria) at a rate of 0,50ml/kg/min for one hour
or no fluid therapy. At the second study day the volunteer will obtain the opposite
treatment.
We will perform BCM measurements every 10 minutes before, during and after the treatment for
6 hours or until the BCM results return to baseline. The results are stored on a BCM patient
card automatically.
The main objective of this study is to detect the administered iv fluid in the extracellular
compartment respectively in FO, TBV and ICV.
Secondary outcome parameters include the change over time of ICV, ECV, TBV and FO after the
iv therapy at the study day "Fluid Therapy".
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02765009 -
Effects of Fluid Balance Control in Critically Ill Patients
|
N/A |