Thermodynamic Model of Hyperthermia in Humans Undergoing HIPEC
ConditionHIPEC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHenry Ford Health System
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (at least 18 years or older)
Scheduled to undergo HIPEC surgery for abdominal cancer at HFH-Main
Disqualifiers
Pregnant females
Minors
Disease not amenable for treatment with HIPEC after surgical examination.
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Additional temperature monitoring/recording
Other interventionAll 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: HIPEC1 intervention
Trial outcomes
Primary outcomes
1
Core-body Temperature (Celsius)
Temperature values over time during a HIPEC treatment.
Time frame
Duration of HIPEC procedure (2-4 hours)2
Bladder temperature (Celsius)
Temperature values over time during a HIPEC treatment.
Time frame
Duration of HIPEC procedure (2-4 hours)Secondary outcomes
1
Mean Temperature of the Skin (C)
Weighed calculation of the skin temperature values over time during a HIPEC treatment.
Time frame
Duration of HIPEC procedure (2-4 hours)2
Intrabdominal wall tissue temperature (Celsius)
Temperature values over time during a HIPEC treatment.
Time frame
Duration of HIPEC procedure (2-4 hours)3
Set Temperature (Celsius)
Temperature values over time during a HIPEC treatment
Time frame
Duration of HIPEC procedure (2-4 hours)4
Inflow Temperature (Celsius)
Temperature values over time during a HIPEC treatment
Time frame
Duration of HIPEC procedure (2-4 hrs)Sponsors and contacts
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Source ClinicalTrials.gov