AI-guided blood-pressure and fluid management during cytoreductive surgery with HIPEC
HEMOdynamic Proactive Management During Cytoreductive Surgery and Intraperitoneal hyPErthermic Chemotherapy for Advanced Ovarian Cancer
NA · Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07070973
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rome) |
| Trial ID | NCT07070973 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Rome
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ovarian Cancer, Hemodynamic Instability, Fluid Overload