Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT07070973

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

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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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Scheduled for cytoreductive surgery for ovarian cancer
Not Eligible

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

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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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