Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07366164

The Assisted Fluid Management For High-Risk Patients During Colorectal Surgery: A Randomised Controlled Clinical Trial

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2026-01-26

80

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the impact of using an automated fluid management system to guide intraoperative fluid therapy in patients undergoing colorectal surgery. The study aims to assess whether this automated guidance can improve hemodynamic stability and reduce episodes of low blood pressure during surgery. The trial is randomized and focuses on optimizing fluid management for high-risk patients. Participants will be randomly assigned to one of two groups. One group will receive fluid therapy guided by an assisted fluid management device, while the control group will receive fluids following a standard hemodynamic protocol. The study compares these two approaches during laparoscopic colorectal surgery to evaluate their effects. During the study, researchers will monitor the amount of fluids given by the end of surgery as the primary outcome. Participants will be observed throughout the surgical procedure to assess hemodynamic stability. The total duration of participation corresponds to the surgical period, with follow-up as needed to ensure patient safety and data collection.

CONDITIONS

Brief Title

Hemodynamic Optimization Using an Artificial Intelligenze System

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients older than 18 years
  • ASA physical status classification 3
  • Scheduled for laparoscopic colorectal surgery
Not Eligible

You will not qualify if you...

  • Refusal to provide consent
  • Body Mass Index greater than 35 kg/m2
  • Urgent surgical cases
  • Pregnancy

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Day of surgery

Participants undergo laparoscopic colorectal surgery where fluids are administered either using an assisted fluid device or standard hemodynamic protocol.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario Policlinico Gemelli

Roma, RM, Italy, 00166

Actively Recruiting

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Research Team

A

andrea russo, medical doctor

P

Paola Aceto, professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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