NCT04961151

Working Toward the Advancement of Recovery Using Modulated Therapeutic Hyperthermia (WARMTH) in Sepsis - Pilot

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Nicholas M Mohr · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this pilot study is to demonstrate the ability to warm critically ill patients with sepsis to a target temperature of 39°C

Detailed description

Participants with sepsis and without fever will be warmed with surface (forced air and conductive wraps) and core (esophageal) warming, and will have the warming devices placed in the ICU. The warming devices will remain in place until the study is completed (36 hours). The heat exchangers will be set to attain a patient target temperature of 39°C as rapidly as possible, after which the forced-air (non-servo) system will be removed, and the conductive system heat exchanger (powering the water blankets and esophageal device, both of which are servo-controlled) will be set to maintain patient temperature at 39°C for the duration of the study period. Once goal temperature has been achieved for 2 consecutive hours, the forced air warming device will be discontinued. Patients will be randomized at this point to Group 1, in which esophageal warming will be discontinued first or to Group 2, in which external conductive warming will be discontinued first. All patients will have usual standard of care labs, vital signs, and imaging for patients undergoing mechanical ventilation in the ICU. For the duration of the 36-hour intervention, patient vital signs, including blood pressure, heart rate, respiratory rate, and vasopressor requirements will be monitored and recorded every 6 hours. Core temperature will be measured and recorded hourly. Patient's clinical status and outcome will be reviewed in the medical chart 7 days after study completion.

Conditions

• Sepsis

Interventions

Type	Name	Description
OTHER	Multimodal therapeutic warming w/ esophageal d/c	In order to evaluate the ability to reliably raise patient temperature to a target of 39.0°C, patients will be warmed with forced air warming, surface conductive warming, and esophageal core warming. After 4 hours at target temperature, esophageal warming will be discontinued.
OTHER	Multimodal therapeutic warming w/ conductive d/c	In order to evaluate the ability to reliably raise patient temperature to a target of 39.0°C, patients will be warmed with forced air warming, surface conductive warming, and esophageal core warming. After 4 hours at target temperature, conductive warming will be discontinued.

Timeline

• Start date: 2021-08-25
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2021-07-14
• Last updated: 2022-11-14

Locations

3 sites across 1 country: United States