Erasme
Brussels, 1070, Belgium
NCT Number: NCT03141411
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 .
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Brussels, 1070, Belgium
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%
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Emergency surgery Arrhythmia (e.g. atrial fibrillation) Aortic regurgitation
Time frame: intraoperative period
defined as preload independent state
Time frame: intraoperative period
amount of cristalloid ( baseline ) AND fluid boluses (250 ml) received
Time frame: intraoperative period
amount of ephedrine, phenylephrine and norepinephrine
Time frame: intraoperative period
FLUID IN - FLUID OUT
Time frame: until 30 days post surgery
see study protocol NCT03039946 for the description of these complications
Time frame: until 30 days post surgery
time spent in ICU and PACU
Erasme University Hospital
Other
Assisted Versus Manual Goal Directed Fluid Therapy in Major Abdominal Surgery
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06993740
Anesthesia, Cardiovascular Diseases
Jakarta, DKI Jakarta, Indonesia
View Trial DetailsNCT05320718
Anesthesia, Local, Regional Anesthesia
Beijing, Beijing Municipality, China
View Trial DetailsNCT05552092
Surgery
Gwangju, South Korea
View Trial DetailsNCT03369210
Anemia, Hematologic Diseases
Aachen, Germany
View Trial Details