Using Artificial Intelligence to Guide Fluid Therapy During Major Cancer Surgery: A Randomized Controlled Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute, Naples

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

American Society of Anesthesiologists (ASA) Physical Status II-IV

Undergoing major abdominal oncologic surgery (open or laparoscopic) with an expected duration >2 hours

Planned invasive arterial pressure monitoring

Disqualifiers

Significant arrhythmias (e.g., persistent atrial fibrillation)

Severe aortic stenosis

Emergency surgery

Sepsis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Artificial Intelligence-Assisted Fluid Management

    Other intervention

    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

    Other intervention

    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.

Treatment groups

176 Participants
are divided into 2 treatment groups
Group A: Standard Fluid ManagementActive comparator 1 intervention
Group B: AI-Assisted Fluid ManagementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Intraoperative Hypotension Burden

The burden of intraoperative hypotension, measured as the time-weighted average (TWA) of intraoperative hypotension, a composite measure that accounts for both the depth and duration of low arterial blood pressure over time. TWA reflects the overall hypotensive burden during surgery by integrating how low blood pressure falls and for how long it remains below predefined thresholds, assessed using continuous invasive blood pressure monitoring

Time frame
From induction of anesthesia to the end of surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: