A PREDICTIVE ALGORITHM IN AORTIC SURGERY | NCT06984302

Studies
A PREDICTIVE ALGORITHM IN AORTIC SURGERY

NCT06984302

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Recruiting

Last Update Posted

Jul 31, 2025Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Hemodynamic

Interventions

proactive therapy

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2025Actual

Primary Completion Date

Jun 1, 2026Estimated

Completion Date

Jun 1, 2027Estimated

First Submitted Date

May 14, 2025

First Submission Date that Met QC Criteria

May 14, 2025

First Posted Date

May 22, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2025

Last Update Posted Date

Jul 31, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

RUSSO ANDREA, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCSPrincipal Investigator

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCSOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
proactive group	Experimental	in this group patients will be managed by a predictive hemodynamic algorithm	Other: proactive therapy
control group	No Intervention	drugs and fluids will be given based on mean arterial pressure and stroke volume variation respectively

Interventions

Name	Type	Description	Arm Group Labels	Other Names
proactive therapy	Other	drugs and fluids will be given based on the hypotension prediction index	proactive group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andrea Russo, medical doctor	Contact	+39-0630153160		andrea.russo@policlinicogemelli.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione Policlinico Universitario Agostino Gemelli	Recruiting	Rome	RM	00148	Italy