Clinical trial NCT03141411: Assisted Fluid Management vs Manual GDFT
Official title: Assisted Versus Manual Goal Directed Fluid Therapy in Major Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing major abdominal surgery and requiring a CO monitoring for fluid management

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%

Eligibility criteria: 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

Primary outcomes:
measure: percentage time spent with SVV < 13%
timeFrame: intraoperative period
Secondary outcomes:
measure: amount of fluid administered
timeFrame: intraoperative period
measure: amount of vasopressors required
timeFrame: intraoperative period
measure: fluid balance
timeFrame: intraoperative period
measure: incidence of major and minor complications
timeFrame: until 30 days post surgery
measure: PACU/ICU and hospital length of stay
timeFrame: until 30 days post surgery
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme
Study officials:
affiliation: Erasme
name: Alexandre Joosten, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joosten A, Hafiane R, Pustetto M, Van Obbergh L, Quackels T, Buggenhout A, Vincent JL, Ickx B, Rinehart J. Practical impact of a decision support for goal-directed fluid therapy on protocol adherence: a clinical implementation study in patients undergoing major abdominal surgery. J Clin Monit Comput. 2019 Feb;33(1):15-24. doi: 10.1007/s10877-018-0156-x. Epub 2018 May 19.