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Assisted Fluid Management vs Manual GDFT

F

Free University of Brussels (ULB)

Status

Completed

Conditions

Surgery

Study type

Observational

Funder types

Other

Identifiers

NCT03141411
P2017/234 - B406201731981

Details and patient eligibility

About

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 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%

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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