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Pilot Trial of External Warming in Septic Patients

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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