NCT01945541

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 18, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2016

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

1.8 years

First QC Date

August 31, 2013

Last Update Submit

July 10, 2020

Conditions

Fluid Overload

Keywords

Intraoperative Fluid AdministrationBody Composition Measurement

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

standard fluid management

NO INTERVENTION

postoperative BMC measurements

body composition monitoring preoperative

ACTIVE COMPARATOR

pre and postoperative BCM measurements

Device: Body Composition Monitoring

Interventions

Body Composition MonitoringDEVICE

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

Also known as: Fresenius Healthcare Germany
body composition monitoring preoperative

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Years

You may not qualify if:

  • liver, heart, kidney failure, patients with pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, A1090, Austria

Location

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Barbara Kabon, MD

    Medical University Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD. MD.

Study Record Dates

First Submitted

August 31, 2013

First Posted

September 18, 2013

Study Start

August 1, 2013

Primary Completion

June 1, 2015

Study Completion

August 24, 2016

Last Updated

July 14, 2020

Record last verified: 2020-07

Locations

AU(1)