跳至主要内容
临床试验/NCT07070973
NCT07070973招募中不适用

HEMOdynamic Proactive Management During Cytoreductive Surgery and Intraperitoneal hyPErthermic Chemotherapy for Advanced Ovarian Cancer

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
52
试验地点
1
主要终点
TIT-SVI

研究概览

简要总结

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.

详细描述

Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is a complex surgical procedure carried out through laparotomic approach. Intraoperative management represents a challenge for anesthesiologist: hemodynamic instability (due to extremely destructive surgery with fluids shift and blood loss), biochemical abnormalities (worsened by cytotoxic chemotherapic agents peritoneal infusion, with profound metabolic acidosis and electrolytes disturbance), and extreme thermal fluctuations related to the different phases of surgery.

CRS-HIPEC is fraught with significant drawbacks: 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. More than 70% of the patients are admitted in Intensive Care Unit after the surgery.

Intraoperative hypotension (IOH) during CRS-HIPEC is common, and as it is associated with the potential for harm [9]. At the same time, extensive fluid resuscitation in peritoneal cancer patients is associated with a poor postoperative outcome, and avoiding fluid overload is recommended. Optimizing flow and pressure requires repeated measurement of both variables and use of established protocols for vasopressor and fluid administration (the so called "individualized hemodynamic management") has been shown to be associated with decreased postoperative complications compared to routine care. Efficient and accurate control of arterial pressure and cardiac output is a major concern during CRS-HIPEC, because it requires frequent manual adjustments of vasopressor infusion rates and timely fluid administration.

A peculiar aspect of CRS-HIPEC is the delicate phase of intraoperative chemotherapy. During this procedure, hyperthermia and the extensive cytolysis caused by the chemotherapeutic drug lead to multifactorial metabolic acidosis and intense vasodilation: managing fluid therapy and vasoconstrictor drugs is often extremely challenging.

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 during CRS-HIPEC.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • age > 18 years
  • patient scheduled for CRS for ovarian cancer

排除标准

  • patients' refusal
  • cardiac arrythmia
  • pregnancy.

研究组 & 干预措施

Proactive monitoring

Experimental

The patients will be managed following an algorithm based on Assisted Fluid Management (AFM) for fluid infusion and on Hypotension Prediction Index (HPI) to titrate vasopressors and inotropes. AFM will be set as "medium" during cytoreductive phase and "restrictive" during HIPEC.

干预措施: Assisted Fluid Management (Device)

Goal Directed Fluid Therapy (GDT)

Active Comparator

The patients have been managed following institutional algorithm aimed to optimize stroke volume index and reduce intraoperative hypotension

干预措施: Goal Directed Fluid Therapy (GDT) (Other)

结局指标

主要结局

TIT-SVI

时间窗: 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.

TWA-MAP<65mmHg

时间窗: 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

时间窗: 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.

次要结局

  • Vasopressors(Perioperative)
  • Fluids(Perioperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

FRASSANITO LUCIANO

Dr Luciano Frassanito

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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