Clinical trial NCT01945541: Body Composition Monitoring(BCM) for Determination of the Fluid Status in Patients Undergoing General Anesthesia
Official title: Body Composition Monitoring for Determination of the Fluid Status in Patients Undergoing General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Overload
Keywords: Intraoperative Fluid Administration
Body Composition Measurement
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-09-18
Enrollment: 73
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

18-80 Years

Exclusion Criteria:

liver, heart, kidney failure, patients with pacemaker

Primary outcomes:
measure: Postoperative overhydration in liter measured by Body Composition Monitor
timeFrame: Measurements will be performed immediatley before and after surgery. The expected time frame will thus be 2-4 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University Vienna
name: Barbara Kabon, MD
role: PRINCIPAL_INVESTIGATOR
References: