Skip to content

Thermodynamic Model of Hyperthermia in Humans Undergoing HIPEC

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05426928
Acronym
HIPEC
Enrollment
30
Registered
2022-06-22
Start date
2022-09-22
Completion date
2027-03-31
Last updated
2025-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIPEC

Keywords

Predictive model, Intraabdominal hyperthermia, Thermodynamics

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.

Interventions

OTHERAdditional 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.

Sponsors

Henry Ford Health System
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Core-body Temperature (Celsius)Duration of HIPEC procedure (2-4 hours)Temperature values over time during a HIPEC treatment.
Bladder temperature (Celsius)Duration of HIPEC procedure (2-4 hours)Temperature values over time during a HIPEC treatment.

Secondary

MeasureTime frameDescription
Set 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
Outflow Temperature (Celsius)Duration of HIPEC procedure (2-4 hours)Temperature values over time during a HIPEC treatment
HIPEC FlowDuration of HIPEC procedure (2-4 hours)Flow values (mL/min) 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
Underbody Blanket 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
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.
Abdominal 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.
Heart Rate (beats/min)Duration of HIPEC procedure (2-4 hours)Heart rate values over time during a HIPEC treatment.
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.
Body fat percentage (%)Preoperative, obtained the day of surgery.Determined by impedancemetry
Weight (Kg)Preoperative, obtained the day of surgery.Participant's weight
Height (m)Preoperative, obtained the day of surgery.Participant's height
Peritoneal Cavity Volume (mL)Preoperative, on average within 3 months prior to surgery.3D-lab post-processing of preoperative CT scans.
Intrabdominal wall tissue temperature (Celsius)Duration of HIPEC procedure (2-4 hours)Temperature values over time during a HIPEC treatment.

Countries

United States

Contacts

Primary ContactKatherine Nowak, PhD
knowak2@hfhs.org313-771-7128

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026