Body Composition Monitoring for Determination of the Fluid Status in Volunteers Undergoing Intravenous Fluid Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Body Composition Monitoring for Determination of the Fluid Status in Volunteers Undergoing Intravenous Fluid Therapy

Conditions
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Fluid Shifts, Body Fluid Compartments

Intervention / Treatment
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* Drug: Elo-mel® (Fresenius Kabi Austria)
* Device: Body Composition Monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteers aged between 18 and 50 years BMI < 30 kg/m2 Written informed consent given by volunteers after being provided with detailed information about the nature, risks, and scope of the clinical study Exclusion Criteria: Implanted pacemaker or defibrillator Limb amputation identified by physical examination Known allergy or hypersensitivity to Elo-Mel Abnormalities in Blood pressure (Hypotension with a systolic BP < 90 mmHg and hypertension with a systolic BP > 160 mmHg) after 5 min resting Cardiac insufficiency (NYHA≥ 2) Renal insufficiency (GFR ≤ 60 ml/min)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fluid Therapy<br>Intravenous isotonic fluid therapy of Elo-mel® (Fresenius Kabi Austria) at a rate of 0,50ml/kg/min for one hour. Body Composition Monitoring every 10 minutes for 6hours. | Drug: Elo-mel® (Fresenius Kabi Austria)<br>* an iv isotonic crystalloid fluid therapy at a rate of 0,50ml/kg/min for one hour.<br>Device: Body Composition Monitoring<br>* BCM measurements every 10 minutes for 6 hours.<br>* Other names: BCM;|
| Placebo Comparator: Zero Therapy<br>Body Composition Monitoring every 10 minutes for 6hours. No intravenous fluid therapy | Device: Body Composition Monitoring<br>* BCM measurements every 10 minutes for 6 hours.<br>* Other names: BCM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition, especially Extracellular Volume, Intracellular Volume, Total Body Fluid Volume and Fluid Overload. | The primary outcome parameter is the correct detection of the iv fluid therapy by a corresponding increase in the parameters ExtraCellular Volume (ECV), Total Body Fluid Volume (TBV) and Fluid Overload (FO). | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change over time of the body fluid compartments after iv fluid therapy | Secondary outcome parameters include the change over time of ICV, ECV, TBV and FO after the iv therapy at the intervention Fuid Therapy. | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioimpedance Spectroscopy, Body Composition Monitor, Fluid Therapy