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Using Artificial Intelligence to Guide Fluid Therapy During Major Cancer Surgery: A Randomized Controlled Trial
Sponsor: National Cancer Institute, Naples
Summary
The goal of this clinical trial is to learn if using artificial intelligence to guide intravenous fluid therapy during major cancer surgery can help keep blood pressure more stable compared with usual care in adult patients undergoing major cancer surgery. The main questions it aims to answer are: * Does artificial intelligence-guided fluid therapy reduce hypotensive events during surgery? * Does this approach improve recovery and reduce complications after major cancer surgery? Researchers will compare artificial intelligence-guided fluid therapy with standard fluid management to see if the artificial intelligence-guided approach provides better support during surgery. Participants will: * Undergo major cancer surgery under general anesthesia * Receive either artificial intelligence-guided fluid management or standard fluid management during surgery * Be monitored during and after surgery as part of routine clinical care * Be followed after surgery to assess recovery and possible complications
Official title: Fluid Optimization in Cancer Surgery With AI-Assisted Management - FOCUS-AFM Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
176
Start Date
2026-02
Completion Date
2029-02
Last Updated
2026-01-09
Healthy Volunteers
No
Conditions
Interventions
Artificial Intelligence-Assisted Fluid Management
In this intervention, intraoperative intravenous fluid management is supported by an artificial intelligence-based clinical decision support system. The system continuously analyzes real-time hemodynamic data derived from standard intraoperative monitoring and provides recommendations for intravenous fluid administration. Clinicians are strongly encouraged to follow these recommendations but retain full responsibility and may accept or override them based on clinical judgment. The intervention is applied during the intraoperative period only and does not replace standard anesthetic care.
Standard fluid management
In this intervention participants receive intraoperative intravenous fluid therapy managed according to usual clinical practice, without artificial intelligence guidance. Fluid administration is determined by the attending clinician based on standard monitoring and clinical judgment.
Locations (1)
IRCCS Istituto Nazionale Tumori "Fondazione G. Pascale"
Naples, Italy