JAMA

ATS 2024: No mortality benefit for IV acetaminophen in sepsis

May 22, 2024

IV acetaminophen is safe but does not significantly improve days alive and free of organ support in critically ill sepsis patients, according to results of the Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery (ASTER) trial. The results were reported at the American Thoracic Society’s annual meeting.

• This phase 2b randomized, double-blind, clinical trial was conducted from October 2021 to April 2023 with a 90-day follow-up. Adults with sepsis and respiratory or circulatory organ dysfunction were enrolled in the ED or ICU of 40 US academic hospitals within 36 hours of presentation. Patients were randomized to 1 g of acetaminophen IV q6h or placebo for 5 days. Of 447 patients enrolled (mean age, 64 years, 51% female, mean Sequential Organ Failure Assessment [SOFA] score, 5.4), 227 were randomized to acetaminophen and 220 to placebo.
• Acetaminophen was safe with no difference in liver enzymes, hypotension, or fluid balance between treatment arms.
• Days alive and free of organ support to day 28 were not meaningfully different for acetaminophen (20.2 days) vs placebo (19.6 days).
• Among 15 secondary outcomes, total, respiratory, and coagulation SOFA scores were significantly lower on days 2 through 4 in the acetaminophen arm as was the rate of development of acute respiratory distress syndrome within 7 days. There was no significant interaction between cell-free hemoglobin levels and acetaminophen.

Source:

Ware LB; National Heart, Lung, and Blood Institute Prevention and Early Treatment of Acute Lung Injury Clinical Trials Network. (2024, May 19). JAMA. Acetaminophen for Prevention and Treatment of Organ Dysfunction in Critically Ill Patients With Sepsis: The ASTER Randomized Clinical Trial. https://pubmed.ncbi.nlm.nih.gov/38762798/