NCT07134530

Advanced Cardiovascular Management in Major Non-cardiac Surgery.

Advanced Cardiovascular Management in Major Non-cardiac Surgery. A Single Center, Randomized, Parallel, Open Label Clinical Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 534 (estimated)
• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single center, randomised and controlled clinical triaI whose aim is to predict and treat in advance, intraoperative hypotension episodes. In particular, the aim of the study is to compare the clinical impact of two different hemodynamic strategies based on the use of different monitoring platforms: the Edwards EV1000 equipped with FloTrac sensor and HemoSphere platform equipped with Acumen Hypotension Prediction Index software and Acumen IQ pressure sensor.

Conditions

• Intraoperative Hypotension

Interventions

Type	Name	Description
DEVICE	HPI-driven intraoperative hemodynamic management strategy	Hemodynamic management protocol based on information detected by Edwards HemoSphere monitor equipped with the Acumen Hypotension Prediction Index software (HPI)
DEVICE	GDT strategy	Current clinical hemodynamic care

Timeline

• Start date: 2024-04-29
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2025-08-21
• Last updated: 2025-08-21

Locations

1 site across 1 country: Italy