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Three Different GHDT ( Goal Hemodynamic Directed Therapy) Strategies for Intraoperative Fluid Management Optimization During Major Abdominal Surgery: A Randomized Controlled Trial

RecruitingNAAges 65 Years - anyAllASST Sette Laghi
NCT06871150 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Major oncological surgery is among the most complex procedures, involving patients with a combination of high-risk factors that can significantly influence immediate postoperative outcomes and quality of life. The intraoperative hemodynamic management of these patients represents a crucial challenge: maintaining cardiovascular stability and fluid balance during the surgery is associated with reduced complications, including acute kidney injury, myocardial ischemia, and sepsis. Literature has shown that intraoperative fluid administration guided by specific algorithms can reduce complications and improve patient outcomes. In recent years, innovations in artificial intelligence (AI) have profoundly changed how hemodynamic variables are managed during surgery. AI enables real-time clinical data processing and offers the possibility to predict imminent hypotension episodes, allowing the med

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📋 Eligibility rules (as published)
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.
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What it tests

  • Flotrac sensor
  • HPI
  • HPI-AFM
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Where

3 sites
ASST Papa Giovanni XXIII
Bergamo, Italy
Humanitas Research Hospital
Rozzano, Italy
University Hospital Varese ASST SetteLaghi
Varese, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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