Acetaminophen for Prevention and Treatment of Organ Dysfunction in Critically Ill Patients With Sepsis: The ASTER Randomized Clinical Trial
Primary resultResult — go to the resultDifference 0.6 95% CI −1.4 to 2.6Authors' conclusion
Intravenous acetaminophen was safe but did not significantly improve days alive and free of organ support in critically ill sepsis patients.
Study context
- Population
- Adults with sepsis and respiratory or circulatory organ dysfunction, enrolled in the ED or ICU of 40 US academic hospitals within 36 hours of presentation
- Participants
- 447 adults
- Comparison
- IV acetaminophen 1 g every 6 h vs placebo for 5 days
- Acetaminophenn = 227
- Placebon = 220reference
- Primary endpoint
- Days alive and free of organ support (mechanical ventilation, vasopressors, and kidney replacement therapy)
- Follow-up
- Day 28
Methodological detailsphase 2b, double-blind, placebo-controlled, multicentre, October 2021 to April 2023, 90-day follow-up
- Phase 2b
- Double-blind
- Placebo-controlled
- Multicentre
- October 2021 to April 2023
- 90-day follow-up
Primary result
As reported in the abstract
Difference
0.6
95% CI −1.4 to 2.6
P = 0.56
By group
Acetaminophen vs Placebo
difference 0.6 (95% CI −1.4 to 2.6); P = 0.56
Secondary outcomes
| Outcome | Acetaminophen | Placebo | Difference (95% CI) | P value | |
|---|---|---|---|---|---|
| Acute respiratory distress syndrome within 7 days | 2.2% | 8.5% | −6.3 (−10.8 to −1.8) | P = 0.01 | |
| −15−10−505Difference (linear scale) |
Total, respiratory and coagulation SOFA scores · days 2 through 4
- Significantly lower in the acetaminophen arm
- Among 15 secondary outcomes
Effect modification by prerandomization plasma cell-free hemoglobin >10 mg/dL (subgroup)
- No significant interaction between cell-free hemoglobin levels and acetaminophen
Safety
Liver enzymes, hypotension, fluid balance
- No difference between treatment arms; acetaminophen was safe
Original publication
Acetaminophen for Prevention and Treatment of Organ Dysfunction in Critically Ill Patients With Sepsis: The ASTER Randomized Clinical Trial. JAMA. Published 6 August 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →