NCT05478564

Hemodynamic Monitoring During Abdominal Aortic Surgery

INTRAOPERATIVE HEMODYNAMIC MANAGEMENT IN ABDOMINAL AORTIC SURGERY GUIDED BY HYPOTENSION PREDICTION INDEX (HPI) - HEMAS Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 63 (actual)
• Sponsor: Humanitas Clinical and Research Center · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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: 1. Time Weighted Average (TWA) of Area Under the Threshold \<0.4 mmHg 2. Incidence of hypotensive events/patient \< 8 (including the expected hypotensive events due to the aortic clamping and unclamping)

Conditions

• Hemodynamic Instability

Interventions

Type	Name	Description
OTHER	Intraoperative fluids and vasoactive drugs management protocol	Limitation of hypotensive events during open surgery for abdominal aorta repair

Timeline

• Start date: 2022-07-26
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2022-07-28
• Last updated: 2025-03-13

Locations

1 site across 1 country: Italy