Hemodynamic Monitoring During Abdominal Aortic Surgery (HEMAS)

Humanitas Clinical and Research Center

Status: Completed

Conditions: Hemodynamic Instability

Treatments: Other: Intraoperative fluids and vasoactive drugs management protocol

Study type: Observational

Funder types: Other

Identifiers

NCT05478564

3236

HEMAS

Details and patient eligibility

About

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

Full 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)

Enrollment: 63 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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