A Multinational Randomized Trial of Mega-Dose Esomeprazole as Anti-Inflammatory Agent in Sepsis
Primary result · Median mean daily SOFA score, first 10 daysResult — go to the resultRisk difference 0.1 95% CI −0.8 to 1.0Authors' conclusion
Among patients with sepsis or septic shock, mega-dose esomeprazole did not reduce organ dysfunction or other patient-related or biological secondary outcomes.
Study context
- Population
- Adults with sepsis or septic shock, 17 ICUs or EDs in 3 countries166 (54%) septic shock
- Participants
- 307 adults
- Comparison
- Mega-dose esomeprazole vs placebo
- Esomeprazolen = 148
- Placebon = 159reference
- Primary endpoint
- Mean daily Sequential Organ Failure Assessment (SOFA) score
- Follow-up
- To day 10
Methodological detailsmultinational, double-blind, placebo-controlled
- Multinational
- Double-blind
- Placebo-controlled
Primary result
Median mean daily SOFA score, first 10 days · first 10 days post-randomization
Risk difference
0.1
95% CI −0.8 to 1.0
P > 0.99
By group
Esomeprazole
5
median · IQR 3–9
Placebo
5
median · IQR 3–8
Esomeprazole vs Placebo
risk difference 0.1 (95% CI −0.8 to 1.0); P > 0.99
As reported in the abstract
Secondary outcomes
Antibiotic-free days, ICU-free days at day 28, all-cause mortality
- No differences in secondary outcomes
Monocyte phenotype after toll-like receptor agonist activation (mechanistic)
- Pro-inflammatory phenotype not affected by esomeprazole therapy
Original publication
A Multinational Randomized Trial of Mega-Dose Esomeprazole as Anti-Inflammatory Agent in Sepsis. Crit Care Med. Published 29 May 2025. doi:10.
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