NCT02706275CompletedNot Applicable
Pilot Randomized Trial of External Warming in Critically Ill Adult Septic Patients
Washington University School of Medicine1 site in 1 country60 target enrollmentStarted: March 1, 2016Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Monocyte human leukocyte antigen (mHLA-DR) expression
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Warming Group
Experimental
External warming via forced air warming
Intervention: External warming (Other)
Control Group
No Intervention
Standard of care body temperature management
Outcomes
Primary Outcomes
Monocyte human leukocyte antigen (mHLA-DR) expression
Time Frame: 48 hours hours following the start of the intervention period
Secondary Outcomes
- Number of patients who acquire nosocomial infections(30 days after diagnosis of sepsis)
- Number of patients in whom the intervention is stopped early secondary to hemodynamic changes related to the intervention(Through study completion, 2 years)
- Interferon (IFN)-gamma production(48 hours following the start of the intervention period)
- Mortality(28 days)
Investigators
Study Sites (1)
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