Thermodynamic Model of Hyperthermia in Humans Undergoing HIPEC
- Conditions
- HIPEC
- Interventions
- Other: Additional temperature monitoring/recording
- Registration Number
- NCT05426928
- Lead Sponsor
- Henry Ford Health System
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Adults (at least 18 years or older)
- Scheduled to undergo HIPEC surgery for abdominal cancer at HFH-Main
- Pregnant females
- Minors
- Disease not amenable for treatment with HIPEC after surgical examination.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HIPEC Additional temperature monitoring/recording 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.
- Primary Outcome Measures
Name Time Method Bladder temperature (Celsius) Duration of HIPEC procedure (2-4 hours) Temperature values over time during a HIPEC treatment.
Core-body Temperature (Celsius) Duration of HIPEC procedure (2-4 hours) Temperature values over time during a HIPEC treatment.
- Secondary Outcome Measures
Name Time Method Outflow Temperature (Celsius) Duration of HIPEC procedure (2-4 hours) Temperature values over time during a HIPEC treatment
HIPEC Flow Duration of HIPEC procedure (2-4 hours) Flow values (mL/min) over time during a HIPEC treatment
Intrabdominal wall tissue temperature (Celsius) Duration of HIPEC procedure (2-4 hours) Temperature values over time during a HIPEC treatment.
Inflow Temperature (Celsius) Duration of HIPEC procedure (2-4 hrs) Temperature values over time during a HIPEC treatment
Underbody Blanket Temperature (Celsius) Duration of HIPEC procedure (2-4 hours) Temperature values over time during a HIPEC treatment
Intrabdominal Cavity Volume (mL) Preoperative, on average within 3 months prior to surgery. 3D-lab post-processing of preoperative CT scans.
Mean Temperature of the Skin (C) Duration of HIPEC procedure (2-4 hours) Weighed calculation of the skin temperature values over time during a HIPEC treatment.
Operating Room Temperature (Celsius) Duration of HIPEC procedure (2-4 hours) Temperature values over time during a HIPEC treatment
Convection Air Blanket Temperature (Celsius) Duration of HIPEC procedure (2-4 hours) Temperature values over time during a HIPEC treatment
Set Temperature (Celsius) Duration of HIPEC procedure (2-4 hours) Temperature values over time during a HIPEC treatment
Heart Rate (beats/min) Duration of HIPEC procedure (2-4 hours) Heart rate values over time during a HIPEC treatment.
Height (m) Preoperative, obtained the day of surgery. Participant's height
Weight (Kg) Preoperative, obtained the day of surgery. Participant's weight
Abdominal Volume (mL) Preoperative, on average within 3 months prior to surgery. 3D-lab post-processing of preoperative CT scans.
Cardiac Output (L/min) Duration of HIPEC procedure (2-4 hours) Cardiac output values over time during a HIPEC treatment.
Stroke Volume Variation (%) Duration of HIPEC procedure (2-4 hours) Stroke volume variation values over time during a HIPEC treatment.
Peritoneal Cavity Volume (mL) Preoperative, on average within 3 months prior to surgery. 3D-lab post-processing of preoperative CT scans.
Blood Pressure (mmHg) Duration of HIPEC procedure (2-4 hours) Blood pressure values over time during a HIPEC treatment.
Body fat percentage (%) Preoperative, obtained the day of surgery. Determined by impedancemetry
Trial Locations
- Locations (1)
Katherine Nowak
🇺🇸Detroit, Michigan, United States