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

NCT02296294 | Completed

• 1 other identifier: BCM Volunteer Study
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Fluid Shifts; Body Fluid Compartments

Keywords

Bioimpedance Spectroscopy, Body Composition Monitor, Fluid Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change over time of the body fluid compartments after iv fluid therapy

  6 hours

Study Arms (2)

Fluid Therapy

ACTIVE COMPARATOR

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); Device: Body Composition Monitoring

Zero Therapy

PLACEBO COMPARATOR

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

Device: Body Composition Monitoring

Interventions

Elo-mel® (Fresenius Kabi Austria) DRUG

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

Fluid Therapy

Body Composition Monitoring DEVICE

BCM measurements every 10 minutes for 6 hours.

Also known as: BCM

Fluid Therapy; Zero Therapy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: November 20, 2014
• Study Start: October 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 14, 2016

Record last verified: 2016-07

Locations

AU (1)