Actively Recruiting
Proactive Hemodynamic Management During Cytoreductive Surgery and HIPEC
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2026-05-11
52
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Proactive Hemodynamic Management During Cytoreductive Surgery and HIPEC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Scheduled for cytoreductive surgery for ovarian cancer
You will not qualify if you...
- Patient refusal
- Cardiac arrhythmia
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
IRCCS Fondazione Policlinico A. Gemelli
Rome, Italy, 00167
Actively Recruiting
Research Team
L
Luciano Frassanito, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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