跳至主要内容
临床试验/NCT05426928
NCT05426928招募中不适用

Development of a Computational, Thermodynamic Model of Intraabdominal Hyperthermia in Humans Undergoing HIPEC

Henry Ford Health System1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年9月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Bladder temperature (Celsius)

研究概览

简要总结

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) is a well-established alternative for patients with peritoneal surface malignancies. Although HIPEC has a predetermined protocol to manage body temperature, the resultant bladder and core-body temperatures are highly variable and unstable in clinical practice. Such results highlight an incomplete understanding of the thermodynamic processes during HIPEC in humans.

Previous clinical and animal investigations have studied abdominal hyperthermia, but a full human model incorporating patient variables, heat delivery, and the impact of the circulatory system and anesthesia in HIPEC has not been established.

This project seeks to develop and validate a computational thermodynamic model using prospective real-world data from humans undergoing HIPEC surgery. It is hypothesized that by incorporating patient, anesthetic, and perfusion-related variables in a thermodynamic model, the temperatures inside and outside the abdomen during HIPEC can be predicted.

详细描述

Peritoneal surface malignancies are a group of cancers arising from rare primary or common secondary tumors. Regardless of the etiology, the prognosis is poor and only a few therapies have shown promising results. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) is a well-established alternative for patients with these malignancies. Still, as many as 46% of patients recur early after treatment.

Although HIPEC has a predetermined protocol to manage body temperature, the resultant bladder and core-body temperatures are highly variable. Age, gender, body mass index, and type and duration of chemotherapy are key factors influencing the incidence and severity of bladder hyperthermia. While clinical and animal investigations have studied abdominal hyperthermia, a full human model incorporating patient variables, heat delivery, and the impact of the circulatory system and anesthesia in HIPEC has not been established.

To bridge this gap in knowledge, this project seeks to develop and validate a computational thermodynamic model using prospective real-world data from humans undergoing HIPEC surgery. It is hypothesized that by incorporating patient, anesthetic, and perfusion-related variables in a thermodynamic model, the temperatures inside and outside the abdomen during HIPEC can be predicted. By predicting temperature changes during HIPEC, clinicians can improve the safety and efficacy of therapeutic hyperthermia.

The hypothesis will be evaluated through two specific aims:

Specific aim 1: To develop a computational, thermodynamic model of intraabdominal hyperthermia for humans undergoing HIPEC. The rationale is that existing thermodynamic models are designed for non-anesthetized or hypothermic humans, implying the need of a new model with the conditions of a HIPEC treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Adults (at least 18 years or older)
  • Scheduled to undergo HIPEC surgery for abdominal cancer at HFH-Main

排除标准

  • Pregnant females
  • Disease not amenable for treatment with HIPEC after surgical examination.

结局指标

主要结局

Bladder temperature (Celsius)

时间窗: Duration of HIPEC procedure (2-4 hours)

Temperature values over time during a HIPEC treatment.

Core-body Temperature (Celsius)

时间窗: Duration of HIPEC procedure (2-4 hours)

Temperature values over time during a HIPEC treatment.

次要结局

  • Outflow Temperature (Celsius)(Duration of HIPEC procedure (2-4 hours))
  • Operating Room Temperature (Celsius)(Duration of HIPEC procedure (2-4 hours))
  • HIPEC Flow(Duration of HIPEC procedure (2-4 hours))
  • Intrabdominal wall tissue temperature (Celsius)(Duration of HIPEC procedure (2-4 hours))
  • Inflow Temperature (Celsius)(Duration of HIPEC procedure (2-4 hrs))
  • Underbody Blanket Temperature (Celsius)(Duration of HIPEC procedure (2-4 hours))
  • Intrabdominal Cavity Volume (mL)(Preoperative, on average within 3 months prior to surgery.)
  • Mean Temperature of the Skin (C)(Duration of HIPEC procedure (2-4 hours))
  • Convection Air Blanket Temperature (Celsius)(Duration of HIPEC procedure (2-4 hours))
  • Set Temperature (Celsius)(Duration of HIPEC procedure (2-4 hours))
  • Heart Rate (beats/min)(Duration of HIPEC procedure (2-4 hours))
  • Height (m)(Preoperative, obtained the day of surgery.)
  • Abdominal Volume (mL)(Preoperative, on average within 3 months prior to surgery.)
  • Cardiac Output (L/min)(Duration of HIPEC procedure (2-4 hours))
  • Stroke Volume Variation (%)(Duration of HIPEC procedure (2-4 hours))
  • Weight (Kg)(Preoperative, obtained the day of surgery.)
  • Peritoneal Cavity Volume (mL)(Preoperative, on average within 3 months prior to surgery.)
  • Blood Pressure (mmHg)(Duration of HIPEC procedure (2-4 hours))
  • Body fat percentage (%)(Preoperative, obtained the day of surgery.)

研究者

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

Carlos E. Guerra

Principal Investigator, Senior Staff Anesthesiologist, Assistant Professor

Henry Ford Health System

研究点 (1)

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