Assisted Fluid Management vs Manual GDFT

Overview

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 .

Full Title of Study: “Assisted Versus Manual Goal Directed Fluid Therapy in Major Abdominal Surgery”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 24, 2017

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%

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Erasme University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alexandre Joosten, M.D, Principal Investigator, Erasme

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