Recruiting

HIPEC

Sponsor:

Henry Ford Health System

Code:

NCT05426928

Conditions

HIPEC

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Additional temperature monitoring/recording

Study Details

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

Study ID

NCT05426928

Start date

Sep 22, 2022

Status verified date

Oct, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Additional 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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Katherine Nowak, PhD

313-771-7128knowak2@hfhs.org

Locations

Katherine Nowak

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Katherine Nowak, PhD

313-771-7128knowak2@hfhs.org

Carlos Guerra, MD

cguerra1@hfhs.org

More Information

Sponsor

Henry Ford Health System

Last update posted

Oct 20, 2025

Last verified

Oct, 2025

Keywords

  • Predictive model
  • Intraabdominal hyperthermia
  • Thermodynamics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2025-10-20.