Clinical Research Directory
Browse clinical research sites, groups, and studies.
Proactive Hemodynamic Management During Cytoreductive Surgery and HIPEC
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.
Official title: HEMOdynamic Proactive Management During Cytoreductive Surgery and Intraperitoneal hyPErthermic Chemotherapy for Advanced Ovarian Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
52
Start Date
2025-09-01
Completion Date
2025-12-31
Last Updated
2025-08-11
Healthy Volunteers
No
Interventions
Assisted Fluid Management
Intraoperative fluid infusion will be regulated according to the Assisted Fluid Management (AFM) software and on Hypotension Prediction Index (HPI) will be used to titrate vasopressors and inotropes.
Goal Directed Fluid Therapy (GDT)
Institutional goal directed therapy protocol used to optimize SVI and reduce intraoperative hypotension