Surgery
Conditions
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%
Interventions
None listed
Sponsors
Erasme University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentage time spent with SVV < 13% | intraoperative period | defined as preload independent state |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| amount of fluid administered | intraoperative period | amount of cristalloid ( baseline ) AND fluid boluses (250 ml) received |
| amount of vasopressors required | intraoperative period | amount of ephedrine, phenylephrine and norepinephrine |
| 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 |
| PACU/ICU and hospital length of stay | until 30 days post surgery | time spent in ICU and PACU |
Countries
Belgium
Outcome results
None listed