Hemodynamic Monitoring During Abdominal Aortic Surgery

Hemodynamic Instability Clinical Trial

— HEMAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05478564
• Other study ID #: HEMAS
• Secondary ID: 3236
• Status: Recruiting
• Start date: July 26, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: November 2022
• Source: Humanitas Clinical and Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Adults patients undergoing abdominal aorta open surgical repair

Exclusion Criteria:

• Emergent/urgent operation

• Age <18 years

• Pregnancy

Related Conditions & MeSH terms

• Hemodynamic Instability

Intervention

Other:
• Intraoperative fluids and vasoactive drugs management protocol
Limitation of hypotensive events during open surgery for abdominal aorta repair

Locations

Country	Name	City	State
Italy	Humanitas Clinical and Research center	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Humanitas Clinical and Research Center

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global time spent in hypotension <10%	Hypotension=mean arterial pressure <65 mmHg for at least 1 minute	Intraoperative period
Secondary	Time Weighted Average (TWA) of Area Under the Threshold <0.4 mmHg	The severity of hypotension during the whole intraoperative surgery	Intraoperative period
Secondary	Incidence of hypotensive events/patient < 8	including the expected hypotensive events due to the aortic clamping and unclamping	Intraoperative period