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NCT05426928 · ClinicalTrials.gov registry record
Thermodynamic Model of Hyperthermia in Humans Undergoing HIPEC
A clinical trial of HIPEC, sponsored by Henry Ford Health System.
- Recruiting
- Registry status
- 30
- Enrollment target
- 1
- Study location
NCT05426928: Recruiting study of HIPEC, sponsored by Henry Ford Health System.
NCT05426928 is a study of HIPEC that is actively recruiting participants, run by Henry Ford Health System. The registered enrollment target is 30 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05426928, a study of HIPEC, is actively recruiting participants, sponsored by Henry Ford Health System.
- RECRUITING
- Registry status
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Temperature values over time during a HIPEC treatment.
Conditions Studied
Interventions
- OTHER Additional temperature monitoring/recording
Study Locations (1)
Michigan
- Katherine Nowak - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-09-22 |
| Est. Completion | 2027-03-31 |
What NCT05426928 shows while recruiting
NCT05426928 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.
The record links to 1 condition, with HIPEC appearing as the primary indexed condition, and to 1 intervention - of which Additional temperature monitoring/recording is the first listed.
NCT05426928 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT05426928 about?
NCT05426928 is a clinical study titled "Thermodynamic Model of Hyperthermia in Humans Undergoing HIPEC". 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...
What is the current status of trial NCT05426928?
This trial is currently recruiting. The enrollment target is 30 participants. The study started on 2022-09-22. Estimated completion is 2027-03-31.
What conditions does trial NCT05426928 study?
This clinical trial studies the following conditions: HIPEC.
What interventions are being tested in trial NCT05426928?
The interventions under investigation include: Additional temperature monitoring/recording (OTHER).
Who is sponsoring clinical trial NCT05426928?
This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05426928 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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