Proactive Hemodynamic Management During Cytoreductive Surgery and HIPEC
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
age > 18 years
patient scheduled for CRS for ovarian cancer
Disqualifiers
patients' refusal
cardiac arrythmia
pregnancy.
Trial design
Design model
Parallel
Treatments tested in this trial
Assisted Fluid Management
DeviceIntraoperative 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)
Other interventionInstitutional goal directed therapy protocol used to optimize SVI and reduce intraoperative hypotension
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: Proactive monitoringExperimental treatment 1 intervention
Group B: Goal Directed Fluid Therapy (GDT)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
TWA-MAP<65mmHg
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.
Time frame
Perioperative2
TIT-SVI
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.
Time frame
PerioperativeSecondary outcomes
1
Vasopressors
Total norepinephrine dose
Time frame
Perioperative2
Fluids
Total amount of intraoperative fluids
Time frame
PerioperativeOther outcomes
1
AFM effectiveness
The fraction of AFM software-prompted boluses that resulted in the desired increase in SVI
Time frame
Perioperative2
PPCs
Incidence of postoperative pulmonary complications
Time frame
Up to one month from the day of surgery3
Hospital costs
Analysis of hospital costs related to the adoption of AFM software in the clinical practice of our hospital
Time frame
At discharge to homeSponsors and contacts
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Source ClinicalTrials.gov