Pilot Trial of External Warming in Septic Patients

The Washington University

Status: Completed

Conditions: Sepsis

Treatments: Other: External warming

Study type: Interventional

Funder types: Other

Identifiers

NCT02706275

201512121

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Warming Group

Experimental group

Description:

External warming via forced air warming

Treatment:

Other: External warming

Control Group

No Intervention group

Description:

Standard of care body temperature management