Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
ID06871150

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

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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)

Treatment

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)

Follow-up

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

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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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