Thermodynamic Model of Hyperthermia in Humans Undergoing HIPEC

Conditions

• HIPEC

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Sep 22, 2022

Status verified

Oct 2025

Primary completion

Dec 30, 2026

Completion

Mar 31, 2027

Study Design

Enrollment

30 participants (estimated)

Arms

• Arm: 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.

Primary Outcome Measure

Core-body Temperature (Celsius) [ Time Frame: Duration of HIPEC procedure (2-4 hours) ]

Central Contacts

• Katherine Nowak, PhD
  313-771-7128
  [email protected]

Locations (1)

Find similar trials in Detroit, MI