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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07134530

Enrollment

534

Registered

2025-08-21

Start date

2024-04-29

Completion date

2026-04-30

Last updated

2025-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative Hypotension

Keywords

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

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.

Interventions

DEVICEHPI-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)

DEVICEGDT strategy

Current clinical hemodynamic care

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
MINS and AKI incidence	within 3 and 7 days after surgery	Clinical impact of any reduction in IOH occurrence or severity

Secondary

Measure	Time frame	Description
Mortality	30 days	—
Cardiac damage	from day 1 to 3	Measure of serum high-specific Troponin I
kidney damage	day 1, day 2 and day 7	measure of creatine
hypotensive events	2 years	severity and time-weighted average

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026