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OpenTrials
Completed

NCT Number: NCT03141411

Assisted Fluid Management vs Manual GDFT

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 .

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasme

Brussels, 1070, Belgium

About this study

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%

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. percentage time spent with SVV < 13%

    Time frame: intraoperative period

    defined as preload independent state

Secondary outcomes

  1. amount of fluid administered

    Time frame: intraoperative period

    amount of cristalloid ( baseline ) AND fluid boluses (250 ml) received

  2. amount of vasopressors required

    Time frame: intraoperative period

    amount of ephedrine, phenylephrine and norepinephrine

  3. fluid balance

    Time frame: intraoperative period

    FLUID IN - FLUID OUT

  4. incidence of major and minor complications

    Time frame: until 30 days post surgery

    see study protocol NCT03039946 for the description of these complications

  5. PACU/ICU and hospital length of stay

    Time frame: until 30 days post surgery

    time spent in ICU and PACU

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

Assisted Versus Manual Goal Directed Fluid Therapy in Major Abdominal Surgery

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 5, 2017
Registry last updated
Aug 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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