Actively Recruiting
Surgical Management and Advanced Real Time Technologies for Fluid Optimization in Major Abdominal Surgery: A Randomized Controlled Trial
Led by ASST Sette Laghi · Updated on 2026-03-25
150
Participants Needed
3
Research Sites
4 weeks
Total Duration
On this page
Sponsors
A
ASST Sette Laghi
Lead Sponsor
H
Humanitas Research Hospital IRCCS, Rozzano-Milan
Collaborating Sponsor
AI-Summary
What this Trial Is About
Major oncological surgery is a complex procedure often involving patients with high-risk factors that can affect immediate postoperative outcomes and quality of life. Managing cardiovascular stability and fluid balance during surgery is critical to reducing complications such as acute kidney injury, myocardial ischemia, and sepsis. This research evaluates the use of artificial intelligence (AI) tools combined with Goal-Directed Hemodynamic Therapy (GDHT) protocols to optimize intraoperative fluid management in patients undergoing major abdominal cancer surgery. The study compares three fluid management strategies during surgery: one using the FLOTRAC sensor for traditional monitoring, another using the Hypotension Prediction Index (HPI) to predict and prevent low blood pressure episodes, and a third combining HPI with Assisted Fluid Management (AFM) software that provides real-time guidance on fluid administration. Each method is designed to help the medical team manage fluids and maintain hemodynamic stability using different levels of AI support. Participants will be monitored before, during, and after surgery with detailed data collected on fluid administration, hemodynamic parameters, and clinical outcomes such as complications, hospital stay length, and mortality. The study will measure differences in fluid volumes used during surgery and track episodes of hypotension, postoperative complications, and intensive care unit stays up to 30 days after discharge. This comprehensive approach aims to improve clinical outcomes and optimize healthcare resource use.
CONDITIONS
Brief Title
Three Different GHDT ( Goal Hemodynamic Directed Therapy) Strategies for Intraoperative Fluid Management Optimization During Major Abdominal Surgery: A Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older
- ASA physical status II, III, or IV
- Elective major abdominal oncological surgery planned
- Revised Cardiac Index Score of 2 or higher
- Planned invasive arterial monitoring during surgery
- Expected surgery duration greater than 120 minutes
You will not qualify if you...
- Emergency or urgent surgeries
- Severe chronic renal failure with creatinine clearance below 30 ml/min
- Chronic heart failure classified as NYHA Class IV
- Pregnant women
- Contraindications to pulse contour hemodynamic monitoring
- Undergoing liver surgery
- Patient refusal
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 - Duration of the surgery (expected greater than 120 minutes)
Participants undergo elective major abdominal oncological surgery with intraoperative fluid management optimized by one of three advanced hemodynamic monitoring technologies (FLOTRAC, HPI, or HPI-AFM). The treatment focuses on maintaining hemodynamic stability and optimizing fluid administration during surgery.
1 intraoperative visit (in-person)
Duration - Up to 30 days after surgery
Participants are monitored for postoperative complications, hospital mortality, and length of hospital or intensive care stay up to 30 days after surgery.
Approximately 1 to 2 visits depending on clinical course
Trial Site Locations
Total: 3 locations
1
ASST Papa Giovanni XXIII
Bergamo, Italy, Italy, 24127
Actively Recruiting
2
Humanitas Research Hospital
Rozzano, Italy, Italy, 20089
Actively Recruiting
3
University Hospital Varese ASST SetteLaghi
Varese, Italy, Italy, 21100
Actively Recruiting
Research Team
L
Luca Guzzetti Luca Guzzetti, MD
G
Giovanni Gallone Giovanni Gallone, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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