Proactive Hemodynamic Management During Cytoreductive Surgery and HIPEC

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Primary outcome measure(s)

• TWA-MAP<65mmHg — Perioperative
  We intend to define two hierarchical primary endpoints. The first primary endpoint will be the time-weighted average (TWA) - MAP less than 65 mmHg (expressed in mmHg) throughout surgery. The second primary endpoint will be the time spent during surgery in an optimized range of SVI (the "in target" range will be defined at the beginning of hemodynamic monitoring). The optimized range of SVI is the range between the patient's baseline SVI rate and the SVI obteined after a 250 ml fluid bolus.
• TIT-SVI — Perioperative
  We intend to define two hierarchical primary endpoints. The first primary endpoint will be the time-weighted average (TWA) - MAP less than 65 mmHg (expressed in mmHg) throughout surgery. The second primary endpoint will be the time spent during surgery in an optimized range of SVI (the "in target" range will be defined at the beginning of hemodynamic monitoring). The optimized range of SVI is the range between the patient's baseline SVI rate and the SVI obteined after a 250 ml fluid bolus.

Trial sites (1)

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