Perioperative medicine & outcomes
Investigating the effectiveness of an intraoperative decision support guided fluid therapy intervention on postoperative outcome of high-risk patients undergoing high-risk abdominal surgery: protocol for an international multicentre stepped-wedge cluster-randomised implementation trial
Study context
- Population
- High-risk patients undergoing high-risk abdominal surgery, 16 academic hospitals in France, Belgium, Canada and the USplanned sample size
- Participants
- 2,000 patients
- Planned comparison
- Assisted Fluid Management (AFM)-guided fluid therapy vs routine care
- Primary endpoint
- Composite of:
- Major complications
- Death
- Follow-up
- 30 days after surgery
Methodological detailsinternational, multicentre, intention-to-treat, Ongoing in 16 academic hospitals; switch time to AFM randomised by an independent statistician, Powered to detect a relative 20% difference in the primary outcome
- International
- Multicentre
- Intention-to-treat
- Ongoing in 16 academic hospitals; switch time to AFM randomised by an independent statistician
- Powered to detect a relative 20% difference in the primary outcome
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Investigating the effectiveness of an intraoperative decision support guided fluid therapy intervention on postoperative outcome of high-risk patients undergoing high-risk abdominal surgery: protocol for an international multicentre stepped-wedge cluster-randomised implementation trial. BJA Open. Published 5 June 2025. doi:10.
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