Advanced Cardiovascular Management in Major Non-cardiac Surgery.

NCT07134530 | Active Not Recruiting

• 1 other identifier: AIMS
• Study Type: interventional
• Target: 534
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Intraoperative hypotension; major non-cardiac surgery; IOH; Acumen Hypotension Prediction Index (HPI) system

Outcome Measures

Primary Outcomes (1)

• MINS and AKI incidence

  Clinical impact of any reduction in IOH occurrence or severity

  within 3 and 7 days after surgery

Secondary Outcomes (4)

• Mortality

  30 days

• Cardiac damage

  from day 1 to 3

• kidney damage

  day 1, day 2 and day 7

• hypotensive events

  2 years

Study Arms (2)

High-risk adult patients undergoing major non cardiac surgery

ACTIVE COMPARATOR

Standard GDT strategy

Device: GDT strategy

high-risk adult patients undergoing major non cardiac surgery

EXPERIMENTAL

HPI-driven intraoperative hemodynamic management strategy

Device: HPI-driven intraoperative hemodynamic management strategy

Interventions

HPI-driven intraoperative hemodynamic management strategy DEVICE

Hemodynamic management protocol based on information detected by Edwards HemoSphere monitor equipped with the Acumen Hypotension Prediction Index software (HPI)

high-risk adult patients undergoing major non cardiac surgery

GDT strategy DEVICE

Current clinical hemodynamic care

High-risk adult patients undergoing major non cardiac surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent as documented by signature (Appendix Informed Consent Form)
• Age ≥ 18 years old
• Surgical indication for major NCS needing general anesthesia
• Anaesthesiologic indication for perioperative arterial cannulation and advanced hemodynamic monitoring

You may not qualify if:

• Informed Refusal as documented by signature (Appendix Informed Consent Form)
• Age ≤ 18 years old
• Severe aortic valvulopathy
• Atrial fibrillation

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Pavia, 27100, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 21, 2025
• Study Start: April 29, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

IT (1)