HEMAS: Hemodynamic Monitoring During Abdominal Aortic Surgery

• Sponsor: Humanitas Clinical and Research Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05478564
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 12.2
• Patients Per Site Per Month: 4.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hemodynamic Instability	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 Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: INTRAOPERATIVE HEMODYNAMIC MANAGEMENT IN ABDOMINAL AORTIC SURGERY GUIDED BY HYPOTENSION PREDICTION INDEX (HPI) - HEMAS Trial
• Actual Study Start Date: Jul 26, 2022
• Anticipated Primary Completion Date: Jul 31, 2023
• Anticipated Study Completion Date: Jul 31, 2023

Outcome Measures

Primary Outcome Measures

1. Global time spent in hypotension <10% [Intraoperative period]

   Hypotension=mean arterial pressure <65 mmHg for at least 1 minute

Secondary Outcome Measures

1. Time Weighted Average (TWA) of Area Under the Threshold <0.4 mmHg [Intraoperative period]

   The severity of hypotension during the whole intraoperative surgery

2. Incidence of hypotensive events/patient < 8 [Intraoperative period]

   including the expected hypotensive events due to the aortic clamping and unclamping

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adults patients undergoing abdominal aorta open surgical repair

Exclusion Criteria:

• Emergent/urgent operation

• Age <18 years

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Humanitas Clinical and Research center	Rozzano	Milan	Italy	20089

Sponsors and Collaborators

• Humanitas Clinical and Research Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Enrico Giustiniano, Dr, Humanitas Clinical and Research Center
• ClinicalTrials.gov Identifier: NCT05478564
• Other Study ID Numbers: HEMAS
• First Posted: Jul 28, 2022
• Last Update Posted: Jul 28, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 28, 2022