Three goal-directed hemodynamic strategies for fluid management during major abdominal cancer surgery

Surgical Management and Advanced Real Time Technologies for Fluid Optimization in Major Abdominal Surgery: A Randomized Controlled Trial

This trial tests whether three goal-directed fluid-management approaches (FLOTRAC, the Hypotension Prediction Index, and HPI combined with Assisted Fluid Management) help people aged 65 and older having major abdominal cancer surgery keep blood pressure stable and reduce complications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: ASST Sette Laghi (Academic / other)
• Locations: 3 sites (Bergamo, Italy and 2 other locations)
• Trial ID: NCT06871150 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized trial in tertiary hospitals comparing three intraoperative hemodynamic strategies for older patients undergoing elective major abdominal oncologic surgery. Patients are randomized to management guided by FLOTRAC, HPI, or HPI plus Assisted Fluid Management (AFM) software, with clinicians retaining final treatment decisions. Continuous arterial waveform monitoring and protocolized fluid/vasopressor guidance aligned with goal-directed hemodynamic therapy will be applied during procedures expected to last over two hours. Outcomes include intraoperative hemodynamic stability and postoperative complications such as acute kidney injury, myocardial ischemia, and infections.

Who should consider this trial

Good fit: Ideal candidates are adults aged 65 or older with ASA II–IV and a revised cardiac index ≥2 who are scheduled for elective major abdominal oncologic surgery with planned invasive arterial monitoring and an expected operative time >120 minutes.

Not a fit: Patients undergoing emergency surgery, those with severe chronic renal failure (creatinine clearance <30 ml/min), NYHA class IV heart failure, liver surgery, pregnancy, or contraindications to pulse-contour monitoring are excluded and unlikely to benefit from these interventions.

Why it matters

Potential benefit: If successful, these approaches could reduce intraoperative hypotension and lower rates of postoperative complications like acute kidney injury, myocardial ischemia, and sepsis.

How similar studies have performed: Previous trials of algorithm-driven and goal-directed intraoperative fluid management, including hypotension prediction tools, have shown reductions in intraoperative hypotension and some postoperative complications, but direct evidence for combining HPI with AFM is limited.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 65 years.
* ASA physical status II-III-IV.
* Patients undergoing elective major abdominal oncological surgery.
* Revised Cardiac Index Score ≥ 2.
* Plan to perform the procedure with invasive arterial monitoring.
* Expected surgical time greater than 120 minutes.

Exclusion Criteria:

* Emergency or urgent surgeries.
* Severe chronic renal failure (creatinine clearance \< 30 ml/min).
* Chronic heart failure (NYHA Class IV).
* Pregnant women.
* Contraindications to pulse contour hemodynamic monitoring.
* Liver surgery.
* Patient refusal.

Where this trial is running

Bergamo, Italy and 2 other locations

• ASST Papa Giovanni XXIII — Bergamo, Italy, Italy (Recruiting)
• Humanitas Research Hospital — Rozzano, Italy, Italy (Recruiting)
• University Hospital Varese ASST SetteLaghi — Varese, Italy, Italy (Recruiting)

Study contacts

• Study coordinator: Luca Guzzetti Luca Guzzetti, MD

Conditions Hemodynamic; GHDT, Hypotension prediction, Assisted Fluid Management