randomized controlled trial

Background: Sepsis, a devastating syndrome of organ dysfunction triggered by a dysregulated host response to infection, remains a leading cause of global mortality. Statins, renowned for lipid-lowering, also exhibit potent anti-inflammatory and endothelial-stabilizing properties, offering a theoretical advantage in the septic milieu. This study investigated whether adjunctive atorvastatin could improve survival and modulate key sepsis-related outcomes.
Methods: In this open-label, randomized controlled trial conducted in the acute medical unit of a tertiary academic center, adult patients with sepsis(defined as suspected infection plus a SOFA score increment of ≥2) were allocated to receive either standard sepsis management plus daily oral atorvastatin 20mg or standard management alone for up to 28 days. The primary endpoint was 28-day all-cause mortality. Secondary endpoints included requirements for organ support, duration of hospitalization, and kinetic changes in C-reactive protein(CRP), procalcitonin(PCT), and lactate. Analysis adhered to intention-to-treat principles.
Results: Sixty-eight patients were randomized(36 atorvastatin, 32 control). While 28-day mortality trended lower in the atorvastatin arm(36% vs. 56% in controls; Risk Difference -20%, 95% CI -45% to 5%), this difference did not achieve statistical significance(p=0.10). Similarly, no significant benefits were observed in organ support needs or hospital stay. Critically, atorvastatin administration led to a significant and more pronounced reduction in both procalcitonin(median change -8 vs 0 ng/ml, p=0.005) and lactate levels(median change -0.95 vs -0.62 mmol/l, p=0.048) by day 7.
Conclusion: While adjunctive atorvastatin did not demonstrably reduce 28-day mortality in this sepsis cohort, its significant impact on attenuating procalcitonin and lactate levels suggests a beneficial modulation of underlying inflammatory and metabolic derangements.