NCT07070973 Proactive Hemodynamic Management During Cytoreductive Surgery and HIPEC
| NCT ID | NCT07070973 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 52 participants in total. It began in 2025-09-01 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is a complex surgical procedure carried out through laparotomic approach. After CRS-HIPEC morbidity and mortality rates go up to 20%-40% and 3% respectively, and acute kidney injury and pulmonary effusion/oedema are the most frequent postoperative complications. Intraoperative hypotension and risk of fluid overload are common. Efficient and accurate control of arterial pressure and cardiac output is a major concern during CRS-HIPEC. The aim of this study is to perform a pilot study describing a hemodynamic management protocol based on artificial intelligence - derived parameters, that allows to implement the standard goal directed therapy (GDT) protocol in term of amount of IOH and stroke volume (SV) optimization. Specifically, this study aims to test the hypotheses that a hemodynamic protocol based on HPI-AFM monitoring compared to standard GDT helps clinicians reduce IOH during surgery and improve the time "in-target" range of SV index. The study cohort will be compared to an historical cohort of 50 patients underwent to CRS-HIPEC between 2022 and 2024, managed with an institutional goal directed therapy protocol.
Eligibility Criteria
Inclusion Criteria: * age \> 18 years * patient scheduled for CRS for ovarian cancer Exclusion Criteria: * patients' refusal * cardiac arrythmia * pregnancy.
Contact & Investigator
Luciano Frassanito
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT07070973 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07070973 currently recruiting?
Yes, NCT07070973 is actively recruiting participants. Contact the research team at luciano.frassanito@policlinicogemelli.it for enrollment information.
Where is the NCT07070973 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT07070973 clinical trial?
NCT07070973 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Luciano Frassanito at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 52 participants.
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