Fact CheckerSign in

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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IRCCS Fondazione Policlinico A. Gemelli
Coordinator of this site? Confirm its status
RomeItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.