Clinical Trials Directory

Trials / Completed

CompletedNCT03141411

Assisted Fluid Management vs Manual GDFT

Assisted Versus Manual Goal Directed Fluid Therapy in Major Abdominal Surgery

Status
Completed
Phase
Study type
Observational
Enrollment
46 (actual)
Sponsor
Erasme University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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%

Conditions

Timeline

Start date
2017-05-10
Primary completion
2017-08-24
Completion
2017-08-24
First posted
2017-05-05
Last updated
2017-08-28

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT03141411. Inclusion in this directory is not an endorsement.