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NCT Number: NCT07366164

Hemodynamic Optimization Using an Artificial Intelligenze System

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,

Recruiting

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Key information

Conditions

Hemodynamic (MAP) Stability Fluid Management

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario Policlinico Gemelli

Roma, RM, 00166, Italy

Location status: Recruiting

Location contact

andrea russo

CONTACT

[email protected]

3333926815

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

assisted fluid therapy

Device

for this intervention, fluids will be administered using an assisted fluid device

Primary outcomes

  1. amounts of fluids

    Time frame: at the end of surgery

    we registered and compared the amounts of administered fluids after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Paola Aceto, professor

CONTACT

[email protected]

andrea russo, medical doctor

CONTACT

[email protected]

+393333926815

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: SIMPLY

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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