6/28/23, 11:02 PM HEAT (acetaminophen) Pathway Feedback Search Clinical Topics Home Studies HEAT (acetaminophen) HEAT (acetaminophen) Disease Sepsis and septic shock Trial question What is the role of acetaminophen in fever among critically ill patients with suspected infection? Study design Multi-center Double blinded RCT Population Characteristics of study participants 35.4% female N = 700 64.6% male 700 patients (242 female, 449 male) Inclusion criteria: patients with fever (body temperature, 38 C) and known or suspected infection Key exclusion criteria: pregnancy, clinically significant rhabdomyolysis, moribund, requirement for ongoing use of non-steroidal anti-inflammatory drugs, AST or ALT > 5 times the ULN, or bilirubin > 2 times the ULN, or any other contraindication to 4 g acetaminophen/day Interventions N=352 acetaminophen (an infusion containing 1 g of intravenous acetaminophen, every 6 hours) N=348 placebo (an infusion of 5% dextrose in water, every 6 hours) Primary outcome Rate of death by 90 days 16.6 16.6 % 15 9 https://web.pathway.md/studies/recxJlJNsNF7nukEe 1/2 6/28/23, 11:02 PM 16.6 % HEAT (acetaminophen) Pathway 15.9 12.5 % 8.3 % 4.2 % No significant difference 0.0 % Acetaminophen Placebo No significant difference in the rate of death by 90 days (15.9% vs. 16.6%; RR 0.96, 96% CI 0.66 to 1.39) Secondary outcomes No significant difference in length of ICU stay (4.1 days vs. 4.2 days; AD -0.1 days, 95% CI -0.7 to 0.4) No significant difference in hospital length of stay (13.7 days vs. 13.8 days; AD -0.01 days, 95% CI -1.6 to 1.6) Safety outcomes No significant difference in liver dysfunction leading to discontinuation of the drug. Conclusion In patients with fever (body temperature, 38 C) and known or suspected infection, acetaminophen was not superior to placebo with respect to the rate of death by 90 days. Reference Young P, Saxena M, Bellomo R et al. Acetaminophen for Fever in Critically Ill Patients with Suspected Infection. N Engl J Med. 2015 Dec 3;373(23):2215-24. Open reference URL https://web.pathway.md/studies/recxJlJNsNF7nukEe 2/2