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Идёт набор NCT05426928

Thermodynamic Model of Hyperthermia in Humans Undergoing HIPEC

Наблюдательное HIPEC

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Additional temperature monitoring/recording.
Кому может быть актуально
Состояния в реестре: HIPEC. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Specific aim 2: To validate our novel computational thermodynamic model using prospective real-world data from humans undergoing HIPEC surgery. Our rationale is that by using real-world data, the initial (SA1) computational model can be optimized and ultimately used to formulate individualized hyperthermia treatments.

Вмешательства

  • Другое Additional temperature monitoring/recording
    All patients in this study will receive the same standard of care treatment for their HIPEC procedure. The only difference will be the use of additional temperature probes to collect more robust data regarding intraabdominal temperature, and the prospective collection of actual boundary conditions of the system.

Первичные конечные точки

  • Core-body Temperature (Celsius) [Срок оценки: Duration of HIPEC procedure (2-4 hours)]
  • Bladder temperature (Celsius) [Срок оценки: Duration of HIPEC procedure (2-4 hours)]
Вторичные конечные точки (12)
  • Mean Temperature of the Skin (C) [Срок оценки: Duration of HIPEC procedure (2-4 hours)]
  • Intrabdominal wall tissue temperature (Celsius) [Срок оценки: Duration of HIPEC procedure (2-4 hours)]
  • Set Temperature (Celsius) [Срок оценки: Duration of HIPEC procedure (2-4 hours)]
  • Inflow Temperature (Celsius) [Срок оценки: Duration of HIPEC procedure (2-4 hrs)]
  • Outflow Temperature (Celsius) [Срок оценки: Duration of HIPEC procedure (2-4 hours)]
  • HIPEC Flow [Срок оценки: Duration of HIPEC procedure (2-4 hours)]
  • Operating Room Temperature (Celsius) [Срок оценки: Duration of HIPEC procedure (2-4 hours)]
  • Underbody Blanket Temperature (Celsius) [Срок оценки: Duration of HIPEC procedure (2-4 hours)]
  • Convection Air Blanket Temperature (Celsius) [Срок оценки: Duration of HIPEC procedure (2-4 hours)]
  • Intrabdominal Cavity Volume (mL) [Срок оценки: Preoperative, on average within 3 months prior to surgery.]
  • Peritoneal Cavity Volume (mL) [Срок оценки: Preoperative, on average within 3 months prior to surgery.]
  • Abdominal Volume (mL) [Срок оценки: Preoperative, on average within 3 months prior to surgery.]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Katherine Nowak — Detroit

Публикации

  • Loke DR, Helderman RFCPA, Rodermond HM, Tanis PJ, Streekstra GJ, Franken NAP, Oei AL, Crezee J, Kok HP. Demonstration of treatment planning software for hyperthermic intraperitoneal chemotherapy in a rat model. Int J Hyperthermia. 2021;38(1):38-54. doi: 10.1080/02656736.2020.1852324. PMID 33487083
  • Ladhari T, Szafnicki K. Modelling of some aspects of a biomedical process: application to the treatment of digestive cancer (HIPEC). 3 Biotech. 2018 Apr;8(4):190. doi: 10.1007/s13205-018-1211-5. Epub 2018 Mar 20. PMID 29564201
  • Stolwijk JA, Nadel ER, Wenger CB, Roberts MF. Development and application of a mathematical model of human thermoregulation. Arch Sci Physiol (Paris). 1973;27(3):303-10. No abstract available. PMID 4807388
  • Severens NM, van Marken Lichtenbelt WD, Frijns AJ, Van Steenhoven AA, de Mol BA, Sessler DI. A model to predict patient temperature during cardiac surgery. Phys Med Biol. 2007 Sep 7;52(17):5131-45. doi: 10.1088/0031-9155/52/17/002. Epub 2007 Aug 7. PMID 17762076

Идентификаторы

NCT: NCT05426928 · 15538

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗