Hemodynamic Monitoring During Abdominal Aortic Surgery (HEMAS)

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

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

Study Overview

• Status: Completed
• Conditions: Hemodynamic Instability
• Intervention / Treatment: Other: Intraoperative fluids and vasoactive drugs management protocol

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 Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• Italy
  • Milan
    • Rozzano, Milan, Italy, 20089
      • Humanitas Clinical and Research center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All adults submitted to open surgery due to abdominal aorta repair

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global time spent in hypotension <10%	Hypotension=mean arterial pressure <65 mmHg for at least 1 minute	Intraoperative period

Secondary Outcome Measures

Outcome Measure	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	including the expected hypotensive events due to the aortic clamping and unclamping	Intraoperative period

Collaborators and Investigators

• Sponsor: Humanitas Clinical and Research Center

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2022
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: HEMAS; 3236 (Other Identifier: Ethical Committee authorization)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No