MedTrace Logo

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

NCT07314853 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2026-01-09

No results posted yet for this study

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

Interventions

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • National Cancer Institute, Naples

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2027-02-28
Completion
2029-02-28

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07314853 on ClinicalTrials.gov