Sepsis
Conditions
Brief summary
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.
Interventions
OTHERExternal 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
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Monocyte human leukocyte antigen (mHLA-DR) expression | 48 hours hours following the start of the intervention period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interferon (IFN)-gamma production | 48 hours following the start of the intervention period | — |
| Number of patients who acquire nosocomial infections | 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 |
| 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 | — |
Countries
United States
Outcome results
None listed