Acetylsalicylic Acid Treatment in Patients With Sepsis and Septic Shock: A Phase 2, Placebo-Controlled, Randomized Clinical Trial
Primary result · Change in SOFA scoreResult — go to the resultMean difference 0.60 95% CI −0.55 to 1.75- stopped early
Authors' conclusion
In this population of septic patients, ASA did not reduce the intensity of organ dysfunction. ASA increased the risk of severe bleeding compared with placebo.
Study context
- Population
- Adults with sepsis ≤48 h and ≥1 severe organ dysfunction (lactate > 4 mmol/L, platelets < 100,000/mm3, PaO2/FiO2 < 200, or septic shock), 5 general ICUs in Brazilplanned 218
- Participants
- 166 adults
- Comparison
- Acetylsalicylic acid (ASA) 200 mg vs placebo for 7 days
- ASAn = 82
- Placebon = 84reference
- Primary endpoint
- Change in Sequential Organ Failure Assessment (SOFA) score between day 0 and day 7 or date of discharge/death
- Follow-up
- Day 7
Methodological detailsphase 2, blinded, parallel-group, placebo-controlled, multicentre, interim safety analyses, Planned sample size 218 with interim safety analyses after 109 and 163 patients; discontinued due to higher frequency of major bleeding with ASA
- Phase 2
- Blinded
- Parallel-group
- Placebo-controlled
- Multicentre
- Interim safety analyses
- Planned sample size 218 with interim safety analyses after 109 and 163 patients; discontinued due to higher frequency of major bleeding with ASA
Primary result
Change in SOFA score
Mean difference
0.60
95% CI −0.55 to 1.75
P = 0.30
Placebo vs ASA
mean difference 0.60 (95% CI −0.55 to 1.75); P = 0.30
As reported in the abstract
Secondary outcomes
- No differences in any of the secondary outcomes
Safety
| Outcome | P value |
|---|---|
| Serious adverse events | P = 0.009 |
| Major bleeding · within 14 days | P = 0.02 |
- Major bleeding: study discontinued due to higher frequency of major bleeding in the ASA group
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Acetylsalicylic Acid Treatment in Patients With Sepsis and Septic Shock: A Phase 2, Placebo-Controlled, Randomized Clinical Trial. Crit Care Med. Published 21 February 2025. doi:10.
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