Assisted Fluid Management vs Manual GDFT
Assisted Versus Manual Goal Directed Fluid Therapy in Major Abdominal Surgery
1 other identifier
observational
46
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2017
CompletedFirst Posted
Study publicly available on registry
May 5, 2017
CompletedStudy Start
First participant enrolled
May 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 24, 2017
CompletedAugust 28, 2017
April 1, 2017
4 months
May 2, 2017
August 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
percentage time spent with SVV < 13%
defined as preload independent state
intraoperative period
Secondary Outcomes (5)
amount of fluid administered
intraoperative period
amount of vasopressors required
intraoperative period
fluid balance
intraoperative period
incidence of major and minor complications
until 30 days post surgery
PACU/ICU and hospital length of stay
until 30 days post surgery
Eligibility Criteria
All patients undergoing major abdominal surgery and requiring a CO monitoring for fluid management
You may qualify if:
- All patients undergoing major abdominal surgery and requiring a CO monitoring for fluid management
You may not qualify if:
- Emergency surgery Arrhythmia (e.g. atrial fibrillation) Aortic regurgitation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erasme
Brussels, 1070, Belgium
Related Publications (1)
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.
PMID: 29779129DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Alexandre Joosten, M.D
Erasme
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2017
First Posted
May 5, 2017
Study Start
May 10, 2017
Primary Completion
August 24, 2017
Study Completion
August 24, 2017
Last Updated
August 28, 2017
Record last verified: 2017-04