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

Fluid Overload Clinical Trial

— BCM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01945541
• Other study ID #: 2059/2012
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: August 24, 2016

Study information

• Verified date: July 2020
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: August 24, 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

18-80 Years

Exclusion Criteria:

liver, heart, kidney failure, patients with pacemaker

Related Conditions & MeSH terms

• Fluid Overload

Intervention

Device:
• Body Composition Monitoring
Pre- and postoperative measurements of body composition (intracellular and extracellular water content)via bioimpedance spectroscopy

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative overhydration in liter measured by Body Composition Monitor		Measurements will be performed immediatley before and after surgery. The expected time frame will thus be 2-4 hours.