AI-guided blood-pressure and fluid management during cytoreductive surgery with HIPEC
Official title: HEMOdynamic Proactive Management During Cytoreductive Surgery and Intraperitoneal hyPErthermic Chemotherapy for Advanced Ovarian Cancer
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07070973 · Data updated 2026-11-12
This trial will test whether an AI-based hemodynamic monitoring protocol during cytoreductive surgery with HIPEC helps adults with ovarian cancer avoid low blood pressure and fluid overload.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 52 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rome) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | November 30, 2026 |
| Study ends | February 1, 2027 |
| Registry record updated | May 11, 2026 |
| Trial ID | NCT07070973 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 years who are scheduled for cytoreductive surgery with HIPEC for ovarian cancer and who do not have cardiac arrhythmias and consent to participate.
✕Probably not a fit
Patients with cardiac arrhythmias, pregnant patients, or those not undergoing CRS-HIPEC for ovarian cancer are excluded and unlikely to receive benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a pilot interventional comparison of an AI-derived hemodynamic protocol (HPI-AFM) versus standard goal-directed therapy during cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC). The protocol uses predictive and flow-derived parameters to guide vasopressor and fluid decisions with the aim of reducing intraoperative hypotension and optimizing stroke volume. Outcomes include amount and duration of intraoperative hypotension, fluid volumes given, and early postoperative complications such as acute kidney injury and pulmonary effusion. The trial is single-center and enrolls adults scheduled for CRS-HIPEC for ovarian cancer, excluding patients with arrhythmias or pregnancy.
Why it matters
Potential benefit: If successful, the AI-guided protocol could reduce episodes of intraoperative hypotension and limit fluid overload, potentially lowering rates of acute kidney injury and pulmonary complications after CRS-HIPEC.
How similar studies have gone: Traditional goal-directed hemodynamic therapy has reduced postoperative complications in other major abdominal surgeries, and early work with AI-derived hypotension prediction tools has shown promise in other surgical settings but remains untested specifically in CRS-HIPEC.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * age \> 18 years * patient scheduled for CRS for ovarian cancer Exclusion Criteria: * patients' refusal * cardiac arrythmia * pregnancy.
Where it's running
-
IRCCS Fondazione Policlinico A. Gemelli
Rome, Italy Recruiting
Study contacts
- Principal investigator: Luciano Frassanito — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Luciano Frassanito, MD
- Email: luciano.frassanito@policlinicogemelli.it
- Phone: +393475256158
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.