title: Assessment of the safety and feasibility of administering antipyretic therapy in critically ill adults: a pilot randomized clinical trial.
abstract: OBJECTIVE
  To assess the safety and feasibility of treating critically ill adults with different fever control strategies.
  
  
  METHODS
  This was a pilot, open-label clinical trial (ClinicalTrials.gov, number NCT01173367) that randomized febrile patients to an aggressive or permissive fever control strategy. For the aggressive and permissive groups, antipyretic therapy (acetaminophen, physical cooling) was administered when the temperature was ≥ 38.3°C and ≥ 40.0°C respectively. The primary outcome was 28-day mortality.
  
  
  RESULTS
  Two hundred patients experienced a fever (31% of the originally projected estimate), among which 26 were randomized to the aggressive (n = 14) or permissive (n = 12) arm. The aggressive group received a greater dose of acetaminophen (2275 mg vs 0 mg, P = .0001), and more frequently received physical cooling than patients in the permissive group (57% vs 8%, P = .01). The mean daily temperature was lower in the aggressive group (37.8°C vs 38.0°C, P = .02). There was no difference in the primary outcome (21% vs 17%, P = 1.0) or in any safety outcome between the treatment groups.
  
  
  CONCLUSIONS
  This study demonstrated the safety and feasibility of administering antipyretic therapy in critically ill adults. The key finding was a lower than expected incidence of fever.
authors.affiliation: Department of Critical Care Medicine, University of Calgary, and Alberta Health Services, Calgary, Alberta, Canada. daniel.niven@albertahealthservices.ca
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Niven
authors.forename: H Tom
authors.initials: HT
authors.lastname: Stelfox
authors.forename: Caroline
authors.initials: C
authors.lastname: Léger
authors.forename: Paul
authors.initials: P
authors.lastname: Kubes
authors.forename: Kevin B
authors.initials: KB
authors.lastname: Laupland
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage* / Q000009:adverse effects; D000368:Aged; D058633:Antipyretics / Q000008:administration & dosage* / Q000009:adverse effects; D016009:Chi-Square Distribution; D016638:Critical Illness; D005240:Feasibility Studies; D005260:Female; D005334:Fever / Q000628:therapy*; D017052:Hospital Mortality; D006801:Humans; D007036:Hypothermia, Induced; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D016896:Treatment Outcome
chemical_list: D058633:Antipyretics; D000082:Acetaminophen