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| ID | Type | Description | Link |
|---|---|---|---|
| 3236 | Other Identifier | Ethical Committee authorization |
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This trial investigates the ability of our istitutional algorithm in maintaining a safe hemodynamics during abdominal aorta open surgery, in terms of limitation of intraoperative hypotension incidence
The present trial includes patients submitted to abdominal aorta open surgery. This type of procedure is very challenging for the hemodynamic management because of the operation per se (during which the surgeon clamp and unclamp the aorta with very significant hemodynamic variations) and because of the altered tone of the vessels due to the general vascular disease such a type of patients is suffering from.
The aim of this study is to verify if the incidence of intraoperative hypotension in terms of severity, lasting and number of episodes, may be reduced by the application of a protocol of hemodynamic management.
Primary endpoint: Global time spent in hypotension <10%.
Secondary Endpoints:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative fluids and vasoactive drugs management protocol | Other | Limitation of hypotensive events during open surgery for abdominal aorta repair |
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| Measure | Description | Time Frame |
|---|---|---|
| Global time spent in hypotension <10% | Hypotension=mean arterial pressure <65 mmHg for at least 1 minute | Intraoperative period |
| Measure | Description | Time Frame |
|---|---|---|
| Time Weighted Average (TWA) of Area Under the Threshold <0.4 mmHg | The severity of hypotension during the whole intraoperative surgery | Intraoperative period |
| Incidence of hypotensive events/patient < 8 |
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Inclusion Criteria:
Exclusion Criteria:
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All adults submitted to open surgery due to abdominal aorta repair
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanitas Clinical and Research center | Rozzano | Milan | 20089 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39948674 | Derived | Giustiniano E, Nisi F, Ferrod F, Lionetti G, Viscido C, Reda A, Piccioni F, Buono G, Cecconi M. Intraoperative hemodynamic management in abdominal aortic surgery guided by the Hypotension Prediction Index: the Hemas multicentric observational study. J Anesth Analg Crit Care. 2025 Feb 13;5(1):7. doi: 10.1186/s44158-024-00222-x. |
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including the expected hypotensive events due to the aortic clamping and unclamping
| Intraoperative period |