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

NCT ID: NCT02296294

Last Updated: 2016-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-07-31

Brief Summary

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

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".

Conditions

Fluid Shifts; Body Fluid Compartments

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Fluid Therapy

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.

Group Type: ACTIVE_COMPARATOR

Elo-mel® (Fresenius Kabi Austria)

Intervention Type: DRUG

an iv isotonic crystalloid fluid therapy at a rate of 0,50ml/kg/min for one hour.

Body Composition Monitoring

Intervention Type: DEVICE

BCM measurements every 10 minutes for 6 hours.

Zero Therapy

Body Composition Monitoring every 10 minutes for 6hours. No intravenous fluid therapy

Group Type: PLACEBO_COMPARATOR

Body Composition Monitoring

Intervention Type: DEVICE

BCM measurements every 10 minutes for 6 hours.

Interventions

Elo-mel® (Fresenius Kabi Austria)

an iv isotonic crystalloid fluid therapy at a rate of 0,50ml/kg/min for one hour.

Intervention Type: DRUG

Body Composition Monitoring

BCM measurements every 10 minutes for 6 hours.

Intervention Type: DEVICE

Other Intervention Names

BCM

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Barbara Kabon

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of Vienna

Vienna, Vienna, Austria

Countries

Austria

Other Identifiers

BCM Volunteer Study

Identifier Type: -

Identifier Source: org_study_id