Assisted Fluid Management vs Manual GDFT

Completed

• Conditions: Surgery

• Registration Number: NCT03141411
• Lead Sponsor: Erasme University Hospital

Brief Summary

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 .

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 Timeline

• Status Verified: 2017-04
• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-05
• Study Start: 2017-05-10
• Primary Completion: 2017-08-24
• Study Completion: 2017-08-24
• Last Update Submitted: 2017-08-25
• Last Update Posted: 2017-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
percentage time spent with SVV < 13%	intraoperative period	defined as preload independent state

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Erasme; 🇧🇪 Brussels, Belgium