NCT05426928 Thermodynamic Model of Hyperthermia in Humans Undergoing HIPEC
| NCT ID | NCT05426928 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Henry Ford Health System |
| Condition | HIPEC |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-09-22 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2022-09-22 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Carlos Guerra, MD
PRINCIPAL INVESTIGATOR
Staff Anesthesiologist
Frequently Asked Questions
Who can join the NCT05426928 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIPEC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05426928 currently recruiting?
Yes, NCT05426928 is actively recruiting participants. Contact the research team at knowak2@hfhs.org for enrollment information.
Where is the NCT05426928 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT05426928 clinical trial?
NCT05426928 is sponsored by Henry Ford Health System. The principal investigator is Carlos Guerra, MD at Staff Anesthesiologist. The trial plans to enroll 30 participants.