Clinical trial · Interventional
Using Artificial Intelligence to Guide Fluid Therapy During Major Cancer Surgery: A Randomized Controlled Trial
Fluid Optimization in Cancer Surgery With AI-Assisted Management - FOCUS-AFM Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Artificial Intelligence (AI) | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cancer Surgery | — | UNRESOLVED | — |
| Fluid Therapy DURING SURGERY | — | UNRESOLVED | — |
| Hemodynamic (MAP) Stability | — | UNRESOLVED | — |
| Neoplasm | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Artificial Intelligence-Assisted Fluid Management | Other | — | UNRESOLVED |
| Standard fluid management | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Fluid Management
- description
- 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.
- interventionNames
- Other: Standard fluid management
- type
- EXPERIMENTAL
- label
- AI-Assisted Fluid Management
- description
- 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.
- interventionNames
- Other: Artificial Intelligence-Assisted Fluid Management
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available