Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Patients older than 18 years
- ASA physical status classification 3
- Scheduled for laparoscopic colorectal surgery
You will not qualify if you...
- Refusal to provide consent
- Body Mass Index greater than 35 kg/m2
- Urgent surgical cases
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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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