Thermodynamic Model of Hyperthermia in Humans Undergoing HIPEC

NCT05426928 | Recruiting

• 1 other identifier: 15538
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

HIPEC

Keywords

Predictive model; Intraabdominal hyperthermia; Thermodynamics

Outcome Measures

Primary Outcomes (2)

• Core-body Temperature (Celsius)

  Temperature values over time during a HIPEC treatment.

  Duration of HIPEC procedure (2-4 hours)

• Bladder temperature (Celsius)

  Temperature values over time during a HIPEC treatment.

  Duration of HIPEC procedure (2-4 hours)

Secondary Outcomes (19)

• Mean Temperature of the Skin (C)

  Duration of HIPEC procedure (2-4 hours)

• Intrabdominal wall tissue temperature (Celsius)

  Duration of HIPEC procedure (2-4 hours)

• Set Temperature (Celsius)

  Duration of HIPEC procedure (2-4 hours)

• Inflow Temperature (Celsius)

  Duration of HIPEC procedure (2-4 hrs)

• Outflow Temperature (Celsius)

  Duration of HIPEC procedure (2-4 hours)

Study Arms (1)

HIPEC

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.

Other: Additional temperature monitoring/recording

Interventions

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.

HIPEC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Adults (at least 18 years or older)
• Scheduled to undergo HIPEC surgery for abdominal cancer at HFH-Main

You may not qualify if:

• Pregnant females
• Minors
• Disease not amenable for treatment with HIPEC after surgical examination.

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Katherine Nowak

Detroit, Michigan, 48202, United States

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Study Officials

• Carlos Guerra, MD

  Staff Anesthesiologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Nowak, PhD

CONTACT

313-771-7128; knowak2@hfhs.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Senior Staff Anesthesiologist, Assistant Professor

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 22, 2022
• Study Start: September 22, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)