Hemodynamic Monitoring During Abdominal Aortic Surgery

Completed

• Conditions: Hemodynamic Instability

• Registration Number: NCT05478564
• Lead Sponsor: Humanitas Clinical and Research Center

Brief 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)

Study Timeline

• Study Start: 2022-07-26
• Study First Submitted: 2022-07-26
• Study First Submitted QC: 2022-07-26
• Study First Posted: 2022-07-28
• Status Verified: 2022-11
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• Adults patients undergoing abdominal aorta open surgical repair

Exclusion Criteria

• Emergent/urgent operation
• Age <18 years
• Pregnancy
• Intra-operative blood loss > or = 3000ml

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Global time spent in hypotension <10%	Intraoperative period	Hypotension=mean arterial pressure \<65 mmHg for at least 1 minute

Secondary Outcome Measures

Name	Time	Method
Time Weighted Average (TWA) of Area Under the Threshold <0.4 mmHg	Intraoperative period	The severity of hypotension during the whole intraoperative surgery
Incidence of hypotensive events/patient < 8	Intraoperative period	including the expected hypotensive events due to the aortic clamping and unclamping

Trial Locations

Locations (1)

Humanitas Clinical and Research center; 🇮🇹 Rozzano, Milan, Italy