Clinical trial NCT04961151: Working Toward the Advancement of Recovery Using Modulated Therapeutic Hyperthermia (WARMTH) in Sepsis - Pilot
Official title: Working Toward the Advancement of Recovery Using Modulated Therapeutic Hyperthermia (WARMTH) in Sepsis - Pilot
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sepsis
Keywords: hyperthermia
fever
sepsis
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Hennepin County Medical Center, Minneapolis
name: Washington University School of Medicine
First posted: 2021-07-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients above the age of 18 years old.
* Patients with sepsis diagnosed within 48 hours of enrollment. For the purpose of this protocol, sepsis onset is defined as administration of intravenous antibiotics in a patient that the treating critical care physician feels is ill from sepsis.
* All qualifying patients must have a sequential organ failure assessment (SOFA) score of 2 or greater at the time of enrollment.
* Patients requiring mechanical ventilation with an expected duration of mechanical ventilation of \>= 2 days.
* Patient maximum baseline documented temperature (within previous 24 hours) \< 38.3°C.

Exclusion Criteria:

* Patients without legally authorized representative able to provide informed consent.
* Patients with contraindication to core warming using an esophageal core warming device, surface warming using conductive heat transfer, and forced air warmer.
* Patients known to be pregnant.
* Patients with \<40 kg of body mass.
* Patients with comfort care only status.
* Patients with contraindications to hyperthermia treatment (acute stroke, acute traumatic brain injury, acute spinal cord injury, post-cardiac arrest, multiple sclerosis, or sickle cell disease).
* Expected continuous dialysis within 48 hours after enrollment.

Primary outcomes:
measure: Feasibility of warming critically ill patients with sepsis using a multimodal sepsis warming protocol.
timeFrame: 36 hours
Secondary outcomes:
measure: Determine the rate of temperature change of patients undergoing a sepsis warming protocol.
timeFrame: 36 hours
measure: Determine the ability of conductive heat wraps vs. conductive esophageal device to maintain therapeutic hyperthermia
timeFrame: 36 hours
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: University of Iowa
name: Nicholas Mohr, MD
role: PRINCIPAL_INVESTIGATOR
References: