Body Composition Monitoring(BCM) for Determination of the Fluid Status in Patients Undergoing General Anesthesia (BCM)

July 10, 2020 updated by: Barbara Kabon, Medical University of Vienna

Body Composition Monitoring for Determination of the Fluid Status in Patients Undergoing General Anesthesia

The purpose of this study is to evaluate a recently developed device, which measures body composition (i.e. the water content of the body) in the perioperative setting. Specifically the investigators will test the hypothesis, that extracellular water content after surgery correlates to the amount of intraoperative infusion and positive fluid balance. Furthermore the investigators will test, if preoperative evaluation of body water helps to determine intraoperative fluid requirements and to guide fluid administration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients undergoing anesthesia and surgery receive intravenous fluids during the procedure. The amount of administered fluid depends on the type of surgery, cardiovascular stability and intraoperative losses like hemorrhage. Fluid overload as well as hypohydration might be detrimental and might adversely effect outcome after surgery. Specifically overhydration results in significant weight gain, tissue edema and increased morbidity. Technically assisted assessment of volume status before surgery may be useful to direct intraoperative fluid administration and to prevent postoperative volume overload. As a prerequisite the investigators will test a recently developed whole-body bioimpedance spectroscopy device to determine the pre-to postoperative fluid distribution. This body composition monitor (BCM, Fresenius Medical Care, Germany) separates between extracellular and intracellular fluid volume non-invasively by applying a frequency sweep from 3-1000 kilohertz through the entire patient via electrodes placed on the wrist and ankle.

The investigators will test the hypothesis that

  1. the amount of administered fluid correlates with the amount of overhydration measured postoperatively.
  2. that preoperative BCM measurements and thus information about the preoperative hydration state might help to guide fluidmanagement and to reduce the amount of over/ hypohydration postoperatively.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

18-80 Years

Exclusion Criteria:

liver, heart, kidney failure, patients with pacemaker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: standard fluid management
postoperative BMC measurements
ACTIVE_COMPARATOR: body composition monitoring preoperative
pre and postoperative BCM measurements
Device: Body Composition Monitoring
Pre- and postoperative measurements of body composition (intracellular and extracellular water content)via bioimpedance spectroscopy
Other Names:
  • Fresenius Healthcare Germany

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative overhydration in liter measured by Body Composition Monitor
Time Frame: Measurements will be performed immediatley before and after surgery. The expected time frame will thus be 2-4 hours.
Measurements will be performed immediatley before and after surgery. The expected time frame will thus be 2-4 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Barbara Kabon, MD, Medical University Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2013

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

August 24, 2016

Study Registration Dates

First Submitted

August 31, 2013

First Submitted That Met QC Criteria

September 14, 2013

First Posted (ESTIMATE)

September 18, 2013

Study Record Updates

Last Update Posted (ACTUAL)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 10, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2059/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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