Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05426928

Thermodynamic Model of Hyperthermia in Humans Undergoing HIPEC

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Additional temperature monitoring/recording

Other

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 outcomes

  1. Core-body Temperature (Celsius)

    Time frame: Duration of HIPEC procedure (2-4 hours)

    Temperature values over time during a HIPEC treatment.

  2. Bladder temperature (Celsius)

    Time frame: Duration of HIPEC procedure (2-4 hours)

    Temperature values over time during a HIPEC treatment.

Secondary outcomes

  1. Mean Temperature of the Skin (C)

    Time frame: Duration of HIPEC procedure (2-4 hours)

    Weighed calculation of the skin temperature values over time during a HIPEC treatment.

  2. Intrabdominal wall tissue temperature (Celsius)

    Time frame: Duration of HIPEC procedure (2-4 hours)

    Temperature values over time during a HIPEC treatment.

  3. Set Temperature (Celsius)

    Time frame: Duration of HIPEC procedure (2-4 hours)

    Temperature values over time during a HIPEC treatment

  4. Inflow Temperature (Celsius)

    Time frame: Duration of HIPEC procedure (2-4 hrs)

    Temperature values over time during a HIPEC treatment

  5. Outflow Temperature (Celsius)

    Time frame: Duration of HIPEC procedure (2-4 hours)

    Temperature values over time during a HIPEC treatment

  6. HIPEC Flow

    Time frame: Duration of HIPEC procedure (2-4 hours)

    Flow values (mL/min) over time during a HIPEC treatment

  7. Operating Room Temperature (Celsius)

    Time frame: Duration of HIPEC procedure (2-4 hours)

    Temperature values over time during a HIPEC treatment

  8. Underbody Blanket Temperature (Celsius)

    Time frame: Duration of HIPEC procedure (2-4 hours)

    Temperature values over time during a HIPEC treatment

  9. Convection Air Blanket Temperature (Celsius)

    Time frame: Duration of HIPEC procedure (2-4 hours)

    Temperature values over time during a HIPEC treatment

  10. Intrabdominal Cavity Volume (mL)

    Time frame: Preoperative, on average within 3 months prior to surgery.

    3D-lab post-processing of preoperative CT scans.

  11. Peritoneal Cavity Volume (mL)

    Time frame: Preoperative, on average within 3 months prior to surgery.

    3D-lab post-processing of preoperative CT scans.

  12. Abdominal Volume (mL)

    Time frame: Preoperative, on average within 3 months prior to surgery.

    3D-lab post-processing of preoperative CT scans.

  13. Blood Pressure (mmHg)

    Time frame: Duration of HIPEC procedure (2-4 hours)

    Blood pressure values over time during a HIPEC treatment.

  14. Heart Rate (beats/min)

    Time frame: Duration of HIPEC procedure (2-4 hours)

    Heart rate values over time during a HIPEC treatment.

  15. Cardiac Output (L/min)

    Time frame: Duration of HIPEC procedure (2-4 hours)

    Cardiac output values over time during a HIPEC treatment.

  16. Stroke Volume Variation (%)

    Time frame: Duration of HIPEC procedure (2-4 hours)

    Stroke volume variation values over time during a HIPEC treatment.

  17. Body fat percentage (%)

    Time frame: Preoperative, obtained the day of surgery.

    Determined by impedancemetry

  18. Weight (Kg)

    Time frame: Preoperative, obtained the day of surgery.

    Participant's weight

  19. Height (m)

    Time frame: Preoperative, obtained the day of surgery.

    Participant's height

Study contacts

Contact information is provided by the study sponsor or research team.

Katherine Nowak, PhD

CONTACT

[email protected]

313-771-7128

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

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

Acronym: HIPEC

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jun 22, 2022
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.