HIPAA Compliant
ISO 27001 CertifiedActively Recruiting
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2026-05-11
52
Participants Needed
1
Research Sites
9 weeks
Total Duration
Researchers are investigating a proactive hemodynamic management approach during cytoreductive surgery CRS combined with hyperthermic intraperitoneal chemotherapy HIPEC for patients with advanced ovarian cancer. This complex surgery carries high risks of complications such as intraoperative hypotension, acute kidney injury, and pulmonary issues. The study aims to test a hemodynamic protocol using artificial intelligence-based parameters to improve management of blood pressure and cardiac output compared to standard goal directed therapy GDT.
CONDITIONS
Proactive Hemodynamic Management During Cytoreductive Surgery and HIPEC
L
Luciano Frassanito, MD
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day
Participants undergo cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) with hemodynamic management using Assisted Fluid Management (AFM) guided by Hypotension Prediction Index (HPI) or standard goal directed therapy to optimize blood pressure and stroke volume during surgery.
1 surgical procedure and immediate post-operative monitoring
Duration - Up to discharge from hospital
Participants are monitored for post-operative complications including pulmonary complications and recovery, with assessment of ICU and hospital length of stay.
Approximately 6 post-operative visits including ICU stay
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor
