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

NCT07314853 | Not Yet Recruiting

• 1 other identifier: FOCUS AFM
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Neoplasm; Cancer; Hemodynamic (MAP) Stability; Cancer Surgery; Artificial Intelligence (AI); Fluid Therapy DURING SURGERY

Keywords

randomized controlled trial; cancer; fluid balance; fluid therapy; artificial intelligence

Outcome Measures

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

  From induction of anesthesia to the end of surgery

Study Arms (2)

Standard Fluid Management

ACTIVE COMPARATOR

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.

Other: Standard fluid management

AI-Assisted Fluid Management

EXPERIMENTAL

Participants assigned to this arm receive intraoperative intravenous fluid therapy supported by an artificial intelligence-based clinical decision support system. The system analyzes real-time hemodynamic data and provides recommendations for fluid administration. Clinicians are strongly encouraged to follow these recommendations but may accept or override them based on clinical judgment.

Other: Artificial Intelligence-Assisted Fluid Management

Interventions

Artificial Intelligence-Assisted Fluid Management OTHER

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.

AI-Assisted Fluid Management

Standard fluid management OTHER

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.

Standard Fluid Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Ability to understand and sign informed consent

You may not qualify if:

• Significant arrhythmias (e.g., persistent atrial fibrillation)
• Severe aortic stenosis
• Emergency surgery
• Sepsis
• End-stage renal disease on dialysis
• Pregnancy
• Impossibility to cannulate the radial artery
• Refusal to participate or refusal of data processing consent

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (1)

IRCCS Istituto Nazionale Tumori "Fondazione G. Pascale"

Naples, 80100, Italy

Location

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

gilda pasta, MD

CONTACT

+393498369411; g.pasta@istitutotumori.na.it

Francesca Bifulco, MD

CONTACT

+393471752075; f.bifulco@istituotumori.na.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2029
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)