Skip to main content
OpenTrials
Completed

NCT Number: NCT01945541

Body Composition Monitoring(BCM) 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, A1090, Austria

About this study

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

  • the amount of administered fluid correlates with the amount of overhydration measured postoperatively.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18-80 Years

Exclusion criteria

liver, heart, kidney failure, patients with pacemaker

Treatment and study plan

Body Composition Monitoring

Device

Pre- and postoperative measurements of body composition (intracellular and extracellular water content)via bioimpedance spectroscopy

Other names: Fresenius Healthcare Germany

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Acronym: BCM

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Sep 18, 2013
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.