Journal
CRITICAL CARE MEDICINE
Volume 50, Issue 6, Pages 924-934Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/CCM.0000000000005470
Keywords
clinical trial; fever; hyperthermia; immunosuppression; sepsis
Categories
Funding
- National Institutes of Health (NIH) [R35GM126928]
- Agency for Healthcare Research and Quality [K08HS025753]
- Washington University Institute of Clinical and Translational Sciences [UL1TR000448, KL2TR000450]
- NIH [K23GM129660]
- Department of Anesthesiology, Division of Clinical and Translational Research at Washington University
- K12 Mentored Training in Implementation Science award [K12HL137942]
- NIH
- National Institute of General Medical Sciences
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This study aimed to test the hypothesis that forced-air warming improves immune function in critically ill afebrile sepsis patients compared to standard temperature management. The results showed no difference in immune function between the two groups, but the group receiving forced-air warming had lower 28-day mortality and more hospital-free days, indicating the importance of forced-air warming in the treatment of critically ill afebrile sepsis.
OBJECTIVES: To test the hypothesis that forced-air warming of critically ill afebrile sepsis patients improves immune function compared to standard temperature management. DESIGN: Single-center, prospective, open-label, randomized controlled trial. SETTING: One thousand two hundred-bed academic medical center. PATIENTS: Eligible patients were mechanically ventilated septic adults with: 1) a diagnosis of sepsis within 48 hours of enrollment; 2) anticipated need for mechanical ventilation of greater than 48 hours; and 3) a maximum temperature less than 38.3 degrees C within the 24 hours prior to enrollment. Primary exclusion criteria included: immunologic diseases, immune-suppressing medications, and any existing condition sensitive to therapeutic hyperthermia (e.g., brain injury). The primary outcome was monocyte human leukocyte antigen (HLA)-DR expression, with secondary outcomes of CD3/CD28-induced interferon gamma (IFN-gamma) production, mortality, and 28-day hospital-free days. INTERVENTIONS: External warming using a forced-air warming blanket for 48 hours, with a goal temperature 1.5 degrees C above the lowest temperature documented in the previous 24 hours. MEASUREMENTS AND MAIN RESULTS: We enrolled 56 participants in the study. No differences were observed between the groups in HLA-DR expression (692 vs 2,002; p = 0.396) or IFN-gamma production (31 vs 69; p = 0.678). Participants allocated to external warming had lower 28-day mortality (18% vs 43%; absolute risk reduction, 25%; 95% CI, 2-48%) and more 28-day hospital-free days (difference, 2.6 d; 95% CI, 0-11.6). CONCLUSIONS: Participants randomized to external forced-air warming did not have a difference in HLA-DR expression or IFN-gamma production. In this pilot study, however, 28-day mortality was lower in the intervention group. Future research should seek to better elucidate the impact of temperature modulation on immune and nonimmune organ failure pathways in sepsis.
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