Thermodynamic Model of Hyperthermia in Humans Undergoing HIPEC
NCT ID: NCT05426928
Last Updated: 2025-10-17
Study Results
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Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2022-09-22
2027-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HIPEC
Adults undergoing cytoreductive surgery and who are deemed eligible for HIPEC after surgical exploration in the operating theatre.
The patients will receive HIPEC according to routine practice, as defined by the surgical oncologist.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Scheduled to undergo HIPEC surgery for abdominal cancer at HFH-Main
Exclusion Criteria
* Minors
* Disease not amenable for treatment with HIPEC after surgical examination.
18 Years
ALL
No
Sponsors
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Henry Ford Health System
OTHER
Responsible Party
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Carlos E. Guerra
Principal Investigator, Senior Staff Anesthesiologist, Assistant Professor
Principal Investigators
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Carlos Guerra, MD
Role: PRINCIPAL_INVESTIGATOR
Staff Anesthesiologist
Locations
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Katherine Nowak
Detroit, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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15538
Identifier Type: -
Identifier Source: org_study_id
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