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Active, Not Recruiting

NCT Number: NCT07134530

Advanced Cardiovascular Management in Major Non-cardiac Surgery.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Intraoperative Hypotension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

GDT strategy

Device

Current clinical hemodynamic care

Primary outcomes

  1. MINS and AKI incidence

    Time frame: within 3 and 7 days after surgery

    Clinical impact of any reduction in IOH occurrence or severity

Secondary outcomes

  1. Mortality

    Time frame: 30 days

  2. Cardiac damage

    Time frame: from day 1 to 3

    Measure of serum high-specific Troponin I

  3. kidney damage

    Time frame: day 1, day 2 and day 7

    measure of creatine

  4. hypotensive events

    Time frame: 2 years

    severity and time-weighted average

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2025
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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