Thermodynamic Model of Hyperthermia in Humans Undergoing HIPEC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Additional temperature monitoring/recording.
- Who it may be relevant to
- Registry conditions: HIPEC. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development of a Computational, Thermodynamic Model of Intraabdominal Hyperthermia in Humans Undergoing HIPEC
Overview
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.
Detailed description
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.
Interventions
- Other 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.
Primary outcome measures
- Core-body Temperature (Celsius) [Time frame: Duration of HIPEC procedure (2-4 hours)]
- Bladder temperature (Celsius) [Time frame: Duration of HIPEC procedure (2-4 hours)]
Secondary outcome measures (12)
- Mean Temperature of the Skin (C) [Time frame: Duration of HIPEC procedure (2-4 hours)]
- Intrabdominal wall tissue temperature (Celsius) [Time frame: Duration of HIPEC procedure (2-4 hours)]
- Set Temperature (Celsius) [Time frame: Duration of HIPEC procedure (2-4 hours)]
- Inflow Temperature (Celsius) [Time frame: Duration of HIPEC procedure (2-4 hrs)]
- Outflow Temperature (Celsius) [Time frame: Duration of HIPEC procedure (2-4 hours)]
- HIPEC Flow [Time frame: Duration of HIPEC procedure (2-4 hours)]
- Operating Room Temperature (Celsius) [Time frame: Duration of HIPEC procedure (2-4 hours)]
- Underbody Blanket Temperature (Celsius) [Time frame: Duration of HIPEC procedure (2-4 hours)]
- Convection Air Blanket Temperature (Celsius) [Time frame: Duration of HIPEC procedure (2-4 hours)]
- Intrabdominal Cavity Volume (mL) [Time frame: Preoperative, on average within 3 months prior to surgery.]
- Peritoneal Cavity Volume (mL) [Time frame: Preoperative, on average within 3 months prior to surgery.]
- Abdominal Volume (mL) [Time frame: Preoperative, on average within 3 months prior to surgery.]
Eligibility criteria
Inclusion criteria
- Adults (at least 18 years or older)
- Scheduled to undergo HIPEC surgery for abdominal cancer at HFH-Main
Exclusion criteria
- Pregnant females
- Minors
- Disease not amenable for treatment with HIPEC after surgical examination.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Katherine Nowak — Detroit
Publications
- 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
Identifiers
NCT: NCT05426928 · 15538