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

NCT ID: NCT01945541

Last Updated: 2020-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-08-24

Brief 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.

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.

Conditions

Fluid Overload

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

standard fluid management

postoperative BMC measurements

Group Type: NO_INTERVENTION

No interventions assigned to this group

body composition monitoring preoperative

pre and postoperative BCM measurements

Group Type: ACTIVE_COMPARATOR

Body Composition Monitoring

Intervention Type: DEVICE

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

Interventions

Body Composition Monitoring

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

Intervention Type: DEVICE

Other Intervention Names

Fresenius Healthcare Germany

Eligibility Criteria

Inclusion Criteria

18-80 Years

Exclusion Criteria

liver, heart, kidney failure, patients with pacemaker

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Barbara Kabon

PD. MD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara Kabon, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University Vienna

Locations

Medical University of Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

2059/2012

Identifier Type: -

Identifier Source: org_study_id