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

NCT04961151 | Withdrawn

• 1 other identifier: H202104263
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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

Conditions

Sepsis

Keywords

hyperthermia; fever; sepsis

Outcome Measures

Primary Outcomes (1)

• Feasibility of warming critically ill patients with sepsis using a multimodal sepsis warming protocol.

  Our primary outcome is the proportion of patients who achieve goal temperature within 6 hours of starting warming. After discontinuing devices, we will monitor the proportion of participants who remain at the goal temperature. Warming will be performed using standard technique per instructions for use for the surface warming wraps, esophageal heat transfer device, and forced air warming device. The heat exchanger will be set to a target patient temperature of 39°C, with patient temperature measured via temperature sensing Foley catheter or rectal temperature sensor. Feedback (servo) control is provided by the heat exchanger (Blanketrol III, Gentherm Medical, Cincinnati, OH), such that the water temperature flow through the warming devices is adjusted automatically to enable attainment of the target temperature. Forced air warming will be used until goal temperature is reached for at least 2 hours, then other devices will be used to maintain temperature.

  36 hours

Secondary Outcomes (2)

• Determine the rate of temperature change of patients undergoing a sepsis warming protocol.

  36 hours

• Determine the ability of conductive heat wraps vs. conductive esophageal device to maintain therapeutic hyperthermia

  36 hours

Study Arms (2)

Conductive Wrap Warming

EXPERIMENTAL

Esophageal warming will be discontinued first

Other: Multimodal therapeutic warming w/ esophageal d/c

Esophageal Warming

EXPERIMENTAL

Conductive wraps will be discontinued first

Other: Multimodal therapeutic warming w/ conductive d/c

Interventions

Multimodal therapeutic warming w/ esophageal d/c OTHER

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.

Conductive Wrap Warming

Multimodal therapeutic warming w/ conductive d/c OTHER

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.

Esophageal Warming

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nicholas M Mohr: lead
• Hennepin County Medical Center, Minneapolis: collaborator
• Washington University School of Medicine: collaborator

Study Sites (3)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Washington University

St Louis, Missouri, 63130, United States

Location

MeSH Terms

Conditions

Sepsis; Hyperthermia; Fever

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Nicholas Mohr, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Emergency Medicine, Anesthesia Critical Care, and Epidemiology

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 14, 2021
• Study Start: August 25, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)