Assisted Fluid Management vs Manual GDFT

August 25, 2017 updated by: Erasme University Hospital

Assisted Versus Manual Goal Directed Fluid Therapy in Major Abdominal Surgery

Goal-directed fluid therapy (GDFT) strategies based on cardiac output (CO) optimization have been shown to benefit moderate- to high-risk surgery patients and have recently been recommended by professional societies in the UK, in France, and in Europe. However, despite the growing evidence, these strategies are often not implemented in current practice. One of the reasons for this lack of implementation is that GDFT strategies, like any other complex clinical protocol, require significant provider attention and vigilance for consistent implementation and it is well known that even under study conditions protocol compliance rates are often not greater than 50%. To overpass this problem, our CO monitoring devices (EV1000, Edwards Lifesciences) have now an incorporated assisted fluid management software. This software determines fluid responsiveness by estimating the predicted change in stroke volume and suggests to the anesthesiologist when fluid is required .

Study Overview

Status

Completed

Conditions

Detailed Description

The aim of this study was to assess an assisted fluid management strategy in a moderate-to-high risk surgical cohort and compare that cohort to matched patients who received manual GDFT. Our hypothesis was that the assisted fluid management system would result in higher mean percentage time spent during surgery with a SVV < 13%

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Erasme

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing major abdominal surgery and requiring a CO monitoring for fluid management

Description

Inclusion Criteria:

  • All patients undergoing major abdominal surgery and requiring a CO monitoring for fluid management

Exclusion Criteria:

Emergency surgery Arrhythmia (e.g. atrial fibrillation) Aortic regurgitation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage time spent with SVV < 13%
Time Frame: intraoperative period
defined as preload independent state
intraoperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
amount of fluid administered
Time Frame: intraoperative period
amount of cristalloid ( baseline ) AND fluid boluses (250 ml) received
intraoperative period
amount of vasopressors required
Time Frame: intraoperative period
amount of ephedrine, phenylephrine and norepinephrine
intraoperative period
fluid balance
Time Frame: intraoperative period
FLUID IN - FLUID OUT
intraoperative period
incidence of major and minor complications
Time Frame: until 30 days post surgery
see study protocol NCT03039946 for the description of these complications
until 30 days post surgery
PACU/ICU and hospital length of stay
Time Frame: until 30 days post surgery
time spent in ICU and PACU
until 30 days post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasme University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2017

Primary Completion (Actual)

August 24, 2017

Study Completion (Actual)

August 24, 2017

Study Registration Dates

First Submitted

May 2, 2017

First Submitted That Met QC Criteria

May 3, 2017

First Posted (Actual)

May 5, 2017

Study Record Updates

Last Update Posted (Actual)

August 28, 2017

Last Update Submitted That Met QC Criteria

August 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • P2017/234 - B406201731981

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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