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Hemodynamic Optimization Using an Artificial Intelligenze System

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07366164
Acronym
SIMPLY
Enrollment
80
Registered
2026-01-26
Start date
2025-10-01
Completion date
2027-01-01
Last updated
2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Management, Hemodynamic (MAP) Stability

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,

Interventions

DEVICEassisted fluid therapy

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

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
amounts of fluidsat the end of surgerywe registered and compared the amounts of administered fluids after surgery

Countries

Italy

Contacts

CONTACTandrea russo, medical doctor
russoandreamd@gmail.com+393333926815
CONTACTPaola Aceto, professor
paola.aceto@policlinicogemelli.it
PRINCIPAL_INVESTIGATORandrea russo

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026