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Clinical Trials in Italy / NCT07134530
Active, not recruiting Not applicable

Advanced Cardiovascular Management in Major Non-cardiac Surgery.

NCT07134530 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Phase
Not applicable
Started
2024-04-29
Last updated
2025-08-21

Condition(s) studied

Intraoperative Hypotension

Investigational drug(s) / intervention(s)

HPI-driven intraoperative hemodynamic management strategyGDT strategy

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)

GDT strategy: Current clinical hemodynamic care

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * Informed Refusal as documented by signature (Appendix Informed Consent Form) * Age ≤ 18 years old * Severe aortic valvulopathy * Atrial fibrillation

Primary outcome measure(s)

  • MINS and AKI incidence — within 3 and 7 days after surgery
    Clinical impact of any reduction in IOH occurrence or severity

Trial sites (1)

FacilityCityRegionStatus
Fondazione IRCCS Policlinico San Matteo di Pavia Pavia Pavia

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07134530 on ClinicalTrials.gov ↗ ← All trials in Italy