Trial reportPloS one2026
Effect of fluoxetine on organ dysfunction and mortality in severe sepsis.
Trial report in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionSepsis is a leading cause of morbidity and mortality in intensive care units, characterized by a dysregulated host response to infection. Recent evidence suggests fluoxetine, a selective serotonin reuptake inhibitor, may exert immunometabolic effects beneficial in sepsis. The aim of this study is to evaluate the effect of fluoxetine on vasopressor duration, organ dysfunction, inflammatory markers, and mortality in adult patients with severe sepsis. MATERIALS AND
methodsIn this single-center, randomized, double-blind, placebo-controlled trial conducted at Ain Shams University Hospitals (December 2024-June 2025), 46 patients with severe sepsis were randomized 1:1 to receive either fluoxetine (40 mg/day) or placebo in addition to standard sepsis care. The primary outcome was vasopressor duration. Secondary outcomes included Sequential Organ Failure Assessment (SOFA) scores, inflammatory biomarkers (CRP, TNF-α, IL-1, procalcitonin), lactate levels, ICU length of stay, and 28-day mortality.
resultsFluoxetine significantly reduced vasopressor duration (6.2 ± 0.4 vs. 7.9 ± 0.8 days; p < 0.001), ICU stay (15.9 ± 1.6 vs. 17.1 ± 1.1 days; p = 0.005), and inflammatory markers by day 7, including TNF-α, IL-1, CRP, and procalcitonin (all p < 0.05). SOFA and APACHE II scores were also lower in the fluoxetine group on days 7 and 10. No significant difference in 28-day mortality was observed (8.7% vs. 17.4%; p = 0.381).
conclusionsFluoxetine as adjunctive therapy in severe sepsis may reduce vasopressor dependence, attenuate inflammation, and shorten ICU stay without increasing adverse effects. Its mortality benefit remains uncertain and warrants further investigation.
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