RecruitingNot ApplicableNCT07070973

Proactive Hemodynamic Management During Cytoreductive Surgery and HIPEC

HEMOdynamic Proactive Management During Cytoreductive Surgery and Intraperitoneal hyPErthermic Chemotherapy for Advanced Ovarian Cancer


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

52 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria2

  • age > 18 years
  • patient scheduled for CRS for ovarian cancer

Exclusion Criteria3

  • patients' refusal
  • cardiac arrythmia
  • pregnancy.

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Interventions

DEVICEAssisted 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.

OTHERGoal Directed Fluid Therapy (GDT)

Institutional goal directed therapy protocol used to optimize SVI and reduce intraoperative hypotension


Locations(1)

IRCCS Fondazione Policlinico A. Gemelli

Rome, Italy

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NCT07070973


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