NCT07070973Recruiting
Proactive Hemodynamic Management During Cytoreductive Surgery and HIPEC
HEMOdynamic Proactive Management During Cytoreductive Surgery and Intraperitoneal hyPErthermic Chemotherapy for Advanced Ovarian Cancer
Source: ClinicalTrials.gov · Last updated 11 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- First submitted
- 30 Jun 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Ovarian cancer
- NCT number
- NCT07070973
What you commit to
- Study type: Interventional
- Planned participants: 52
- From 1 Sept 2025 to the primary completion date, 30 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- cardiac arrythmia
Other
- patients' refusal
- pregnancy.
Who the study is looking for
- age \> 18 years
- patient scheduled for CRS for ovarian cancer
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Fondazione Policlinico A. Gemelli Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.