Assisted Versus Manual Goal Directed Fluid Therapy in Major Abdominal Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Surgery
- Sponsor
- Erasme University Hospital
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- percentage time spent with SVV < 13%
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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%
Investigators
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
Outcomes
Primary Outcomes
percentage time spent with SVV < 13%
Time Frame: intraoperative period
defined as preload independent state
Secondary Outcomes
- amount of vasopressors required(intraoperative period)
- PACU/ICU and hospital length of stay(until 30 days post surgery)
- amount of fluid administered(intraoperative period)
- fluid balance(intraoperative period)
- incidence of major and minor complications(until 30 days post surgery)