Hemodynamic Optimization Using an Artificial Intelligenze... | NCT07366164

Studies
Hemodynamic Optimization Using an Artificial Intelligenze System

NCT07366164

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Recruiting

Last Update Posted

Jan 26, 2026Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Hemodynamic (MAP) Stability
Fluid Management

Interventions

assisted fluid 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

Jan 2026

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

Oct 1, 2025Actual

Primary Completion Date

Jun 1, 2026Estimated

Completion Date

Jan 1, 2027Estimated

First Submitted Date

Sep 10, 2025

First Submission Date that Met QC Criteria

Jan 16, 2026

First Posted Date

Jan 26, 2026Actual

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

Jan 16, 2026

Last Update Posted Date

Jan 26, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

RUSSO ANDREA, Principal Investigator, 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

This study will investigate the impact of using an automated fluid management system on intraoperative fluid therapy in patients undergoing colorectal surgery. The aim is to evaluate whether automated guidance can optimize hemodynamic stability and reduce the incidence of arterial hypotension,

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
treatment group	Experimental	fluid therpay fo this grioup will be giuded through the assisted fluid management system	Device: assisted fluid therapy
control group	No Intervention	patients belonging to this group will receive fluids following a standard hemodynamic protocol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
assisted fluid therapy	Device	for this intervention, fluids will be administered using an assisted fluid device	treatment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
amounts of fluids	we registered and compared the amounts of administered fluids after surgery	at the end of surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- patients >18 years old and ASA 3 scheduled for laparoscopic colorectal surgery

Exclusion Criteria:

Refusal of consent
Body Mass Index > 35 kg/m2
urgent cases
pregnancy

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	+393333926815		russoandreamd@gmail.com
Paola Aceto, professor	Contact			paola.aceto@policlinicogemelli.it

Overall Officials

Name	Affiliation	Role
andrea russo	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione Policlinico Universitario Policlinico Gemelli	Recruiting	Roma	RM	00166	Italy