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

NCT ID: NCT04961151

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-25
• Study Completion Date: 2022-07-01

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.

Conditions

Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conductive Wrap Warming

Esophageal warming will be discontinued first

Group Type: EXPERIMENTAL

Multimodal therapeutic warming w/ esophageal d/c

Intervention Type: 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.

Esophageal Warming

Conductive wraps will be discontinued first

Group Type: EXPERIMENTAL

Multimodal therapeutic warming w/ conductive d/c

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hennepin County Medical Center, Minneapolis

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

Nicholas M Mohr

OTHER

Sponsor Role: lead

Responsible Party

Nicholas M Mohr

Professor of Emergency Medicine, Anesthesia Critical Care, and Epidemiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nicholas Mohr, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Washington University

St Louis, Missouri, United States

Countries

United States

Other Identifiers

H202104263

Identifier Type: -

Identifier Source: org_study_id