Clinical trial NCT05426928: Thermodynamic Model of Hyperthermia in Humans Undergoing HIPEC
Official title: Development of a Computational, Thermodynamic Model of Intraabdominal Hyperthermia in Humans Undergoing HIPEC
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIPEC
Keywords: Predictive model
Intraabdominal hyperthermia
Thermodynamics
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of all patients who are scheduled to undergo hyperthermic intraperitoneal chemotherapy (HIPEC) for abdominal cancer at Henry Ford Main Hospital

Brief summary: 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.

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.

Primary outcomes:
measure: Core-body Temperature (Celsius)
timeFrame: Duration of HIPEC procedure (2-4 hours)
measure: Bladder temperature (Celsius)
timeFrame: Duration of HIPEC procedure (2-4 hours)
Secondary outcomes:
measure: Mean Temperature of the Skin (C)
timeFrame: Duration of HIPEC procedure (2-4 hours)
measure: Intrabdominal wall tissue temperature (Celsius)
timeFrame: Duration of HIPEC procedure (2-4 hours)
measure: Set Temperature (Celsius)
timeFrame: Duration of HIPEC procedure (2-4 hours)
measure: Inflow Temperature (Celsius)
timeFrame: Duration of HIPEC procedure (2-4 hrs)
measure: Outflow Temperature (Celsius)
timeFrame: Duration of HIPEC procedure (2-4 hours)
measure: HIPEC Flow
timeFrame: Duration of HIPEC procedure (2-4 hours)
measure: Operating Room Temperature (Celsius)
timeFrame: Duration of HIPEC procedure (2-4 hours)
measure: Underbody Blanket Temperature (Celsius)
timeFrame: Duration of HIPEC procedure (2-4 hours)
measure: Convection Air Blanket Temperature (Celsius)
timeFrame: Duration of HIPEC procedure (2-4 hours)
measure: Intrabdominal Cavity Volume (mL)
timeFrame: Preoperative, on average within 3 months prior to surgery.
measure: Peritoneal Cavity Volume (mL)
timeFrame: Preoperative, on average within 3 months prior to surgery.
measure: Abdominal Volume (mL)
timeFrame: Preoperative, on average within 3 months prior to surgery.
measure: Blood Pressure (mmHg)
timeFrame: Duration of HIPEC procedure (2-4 hours)
measure: Heart Rate (beats/min)
timeFrame: Duration of HIPEC procedure (2-4 hours)
measure: Cardiac Output (L/min)
timeFrame: Duration of HIPEC procedure (2-4 hours)
measure: Stroke Volume Variation (%)
timeFrame: Duration of HIPEC procedure (2-4 hours)
measure: Body fat percentage (%)
timeFrame: Preoperative, obtained the day of surgery.
measure: Weight (Kg)
timeFrame: Preoperative, obtained the day of surgery.
measure: Height (m)
timeFrame: Preoperative, obtained the day of surgery.
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Katherine Nowak
state: Michigan
Study officials:
affiliation: Staff Anesthesiologist
name: Carlos Guerra, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.