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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-risk adult patients undergoing major non cardiac surgery | Active Comparator | Standard GDT strategy |
|
| high-risk adult patients undergoing major non cardiac surgery | Experimental | HPI-driven intraoperative hemodynamic management strategy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| MINS and AKI incidence | Clinical impact of any reduction in IOH occurrence or severity | within 3 and 7 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 30 days | |
| Cardiac damage | Measure of serum high-specific Troponin I | from day 1 to 3 |
| kidney damage |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Policlinico San Matteo di Pavia | Pavia | Pavia | 27100 | Italy |
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| GDT strategy | Device | Current clinical hemodynamic care |
|
measure of creatine |
| day 1, day 2 and day 7 |
| hypotensive events | severity and time-weighted average | 2 years |