Intraoperative HypotensionNCT07134530
Advanced Cardiovascular Management in Major Non-cardiac Surgery.
A study testing HPI-driven intraoperative hemodynamic management strategy and GDT strategy in people with Intraoperative Hypotension, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraoperative Hypotension
- What is being tested?
- HPI-driven intraoperative hemodynamic management strategy and GDT strategy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 534 participants
- Where
- 1 siteItaly
- Study dates
- 29 Apr 2024to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Informed Refusal as documented by signature (Appendix Informed Consent Form)
- Age ≤ 18 years old
- Severe aortic valvulopathy
- Atrial fibrillation
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Pavia, 27100
About this study
Official title: Advanced Cardiovascular Management in Major Non-cardiac Surgery. A Single Center, Randomized, Parallel, Open Label Clinical Trial
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
- Being tested
- HPI-driven intraoperative hemodynamic management strategy, GDT strategy
- Keywords
- Intraoperative hypotension, major non-cardiac surgery, IOH, Acumen Hypotension Prediction Index (HPI) system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPI-driven intraoperative hemodynamic management strategyDevice
Hemodynamic management protocol based on information detected by Edwards HemoSphere monitor equipped with the Acumen Hypotension Prediction Index software (HPI)
GDT strategyDevice
Current clinical hemodynamic care
| Study group | Role | What they receive |
|---|---|---|
| High-risk adult patients undergoing major non cardiac surgery | Active comparator | Standard GDT strategy Receives: Device: GDT strategy |
| high-risk adult patients undergoing major non cardiac surgery | Experimental | HPI-driven intraoperative hemodynamic management strategy Receives: Device: HPI-driven intraoperative hemodynamic management strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MINS and AKI incidence
Clinical impact of any reduction in IOH occurrence or severity
Measured: within 3 and 7 days after surgery
Secondary outcomes (4)
Mortality
Measured: 30 days
Cardiac damage
Measure of serum high-specific Troponin I
Measured: from day 1 to 3
kidney damage
measure of creatine
Measured: day 1, day 2 and day 7
hypotensive events
severity and time-weighted average
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start29 Apr 2024
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 534 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Locatelli, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134530
- Sponsor's protocol ID
- AIMS
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Cardiovascular Management in Major Non-cardiac Surgery. A Single Center, Randomized, Parallel, Open Label Clinical Trial
- ClinicalTrials.gov ID
- NCT07134530
- Acronym / sponsor ID
- AIMS
- Conditions
- Intraoperative Hypotension
- Keywords
- Intraoperative hypotension, major non-cardiac surgery, IOH, Acumen Hypotension Prediction Index (HPI) system
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 534 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-risk adult patients undergoing major non cardiac surgery | Active comparator | Device: GDT strategyStandard GDT strategy |
| high-risk adult patients undergoing major non cardiac surgery | Experimental | Device: HPI-driven intraoperative hemodynamic management strategyHPI-driven intraoperative hemodynamic management strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Informed Refusal as documented by signature (Appendix Informed Consent Form)
- Age ≤ 18 years old
- Severe aortic valvulopathy
- Atrial fibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPI-driven intraoperative hemodynamic management strategyHemodynamic management protocol based on information detected by Edwards HemoSphere monitor equipped with the Acumen Hypotension Prediction Index software (HPI) | Device | high-risk adult patients undergoing major non cardiac surgery |
| GDT strategyCurrent clinical hemodynamic care | Device | High-risk adult patients undergoing major non cardiac surgery |
Primary outcome
MINS and AKI incidence
Time frame: within 3 and 7 days after surgery
Clinical impact of any reduction in IOH occurrence or severity
4 secondary outcomes
Mortality
Time frame: 30 days
Cardiac damage
Time frame: from day 1 to 3
kidney damage
Time frame: day 1, day 2 and day 7
hypotensive events
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
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Carotid Artery Blood Flow, Blood Pressure, and Cardiac Output During Anesthesia in Children Aged 0-5 Years
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Machine Learning-Assisted Management of Intraoperative Hypotension for Personalized Treatment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPI-driven intraoperative hemodynamic management strategy and GDT strategy in people with Intraoperative Hypotension, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MINS and AKI incidence (time frame: within 3 and 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.