Pilot Trial of External Warming in Septic Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Sepsis

Intervention / Treatment
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* Other: External warming


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Warming Group<br>External warming via forced air warming | Other: External warming<br>* 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<br>|
| No Intervention: Control Group<br>Standard of care body temperature management | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interferon (IFN)-gamma production |  | 48 hours following the start of the intervention period | 
| Number of patients who acquire nosocomial infections | 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 | 
| Mortality |  | 28 days | 
| Number of patients in whom the intervention is stopped early secondary to hemodynamic changes related to the intervention |  | Through study completion, 2 years |