Pilot Trial of External Warming in Septic Patients

April 27, 2020 updated by: Washington University School of Medicine

Pilot Randomized Trial of External Warming in Critically Ill Adult Septic Patients

The purpose of this study is to determine whether externally warming critically ill afebrile adult septic patients will improve indices of immune function and/or clinical outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Admitted to a surgical or medical intensive care unit
  • Age greater than 18 years
  • Diagnosis of sepsis within 24 hours of enrollment
  • Requirement for mechanical ventilation with expected duration of mechanical ventilation > 48 hours
  • Goal Richmond Agitation Sedation Scale (RASS) < 0
  • Maximum baseline temperature (within previous 24 hours) < 38.3°C

Exclusion Criteria:

  • Treatment with chemotherapy within 6 months of enrollment
  • Treatment with corticosteroids at a dose > 300 mg/day hydrocortisone (or equivalent)
  • History of solid organ transplant on any immunosuppression medication
  • History of immunological disease
  • History of chronic infection with hepatitis B or C virus
  • History of acute stroke, acute coronary syndrome, or severe head injury requiring osmotic therapy within 7 days prior to enrollment
  • History of multiple sclerosis
  • Contraindications to both bladder or esophageal core temperature monitors or to forced air warming blankets
  • Moribund status
  • Sepsis without source control

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Warming Group
External warming via forced air warming
Other: External warming
External warming via forced air warming to a goal body temperature 1.5°C greater than the baseline minimum temperature (within previous 24 hours) for 48 hours
No Intervention: Control Group
Standard of care body temperature management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Monocyte human leukocyte antigen (mHLA-DR) expression
Time Frame: 48 hours hours following the start of the intervention period
48 hours hours following the start of the intervention period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 28 days
28 days
Interferon (IFN)-gamma production
Time Frame: 48 hours following the start of the intervention period
48 hours following the start of the intervention period
Number of patients who acquire nosocomial infections
Time Frame: 30 days after diagnosis of sepsis
Number of patients who develop a nosocomial infection (defined as a new infection diagnosed greater than 48 hours after the original sepsis diagnosis) within 30 days of the sepsis diagnosis
30 days after diagnosis of sepsis
Number of patients in whom the intervention is stopped early secondary to hemodynamic changes related to the intervention
Time Frame: Through study completion, 2 years
Through study completion, 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

May 12, 2019

Study Completion (Actual)

May 12, 2019

Study Registration Dates

First Submitted

March 1, 2016

First Submitted That Met QC Criteria

March 7, 2016

First Posted (Estimate)

March 11, 2016

Study Record Updates

Last Update Posted (Actual)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 27, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 201512121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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