A PREDICTIVE ALGORITHM IN AORTIC SURGERY

NCT ID: NCT06984302

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2027-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hemodynamic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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proactive group

in this group patients will be managed by a predictive hemodynamic algorithm

Group Type EXPERIMENTAL

proactive therapy

Intervention Type OTHER

drugs and fluids will be given based on the hypotension prediction index

control group

drugs and fluids will be given based on mean arterial pressure and stroke volume variation respectively

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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proactive therapy

drugs and fluids will be given based on the hypotension prediction index

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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RUSSO ANDREA

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fondazione Policlinico Universitario Agostino Gemelli

Rome, RM, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Andrea Russo, medical doctor

Role: CONTACT

+39-0630153160

Facility Contacts

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Andrea Russo

Role: primary

+39-06-30153160

Other Identifiers

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7458

Identifier Type: -

Identifier Source: org_study_id

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