A PREDICTIVE ALGORITHM IN AORTIC SURGERY (HYVAS)

July 30, 2025 updated by: RUSSO ANDREA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

HYPOTENSION PREDICTION INDEX FOR HEMODYNAMIC OPTIMIZATION IN MAJOR VASCULAR SURGERY

We will enroll patients scheduled for abdominal aortic aneurysm repair and divide in two groups; in the control group the hemodynamic optimization will be made based on standard cardiovascular parameters showed in the Hemosphere platform. In the interventional group the hemodynamic optimization will be made based on the hypotension prediction index.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • planned aortic surgery acceptance of written informed consent

Exclusion Criteria:

  • body mass index > 35 kg/m2
  • atrial fibrillation
  • urgent surgery
  • end-stage renal disease
  • pregnancy
  • refusal of the consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: proactive group
in this group patients will be managed by a predictive hemodynamic algorithm
Other: proactive therapy
drugs and fluids will be given based on the hypotension prediction index
No Intervention: control group
drugs and fluids will be given based on mean arterial pressure and stroke volume variation respectively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time weighted average of mean arterial presure under 65 mmHg
Time Frame: at the end of surgery
we will assess the magnitude of intraoperative arterial hypotension
at the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

May 14, 2025

First Submitted That Met QC Criteria

May 14, 2025

First Posted (Actual)

May 22, 2025

Study Record Updates

Last Update Posted (Actual)

July 31, 2025

Last Update Submitted That Met QC Criteria

July 30, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 7458

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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