Dados do Trabalho

Título

Impact of Aspirin Use on the Severity of Organ Dysfunctions in Patients With Sepsis and Septic Shock: a Randomized, Double-blind, Placebo-controlled Trial - ASP-SEPSIS

Objetivo

Objectives: To evaluate whether the use of aspirin reduces the intensity of organ dysfunction measured by the Sequential Organ Failure Score (SOFA).

Métodos

Methods: A phase II randomized, placebo controlled, blinded study in 5 ICU in patients over 18 years old, within 48 hours of sepsis and/or septic shock onset who had one of the following: lactate>4mmol/L, platelets<105/mm3, PaO2/FiO2 < 200 or septic shock. Patients in the intervention group received 100 mg of aspirin for 7 days. Primary outcome was SOFA score variation between D0 and D7. Secondary outcomes included ICU and hospital mortality, mechanical ventilation, vasopressor and ICU free-days in 28 days, and renal replacement therapy. Safety outcomes were severe bleeding and number of transfusions within 14 days. An intention-to-treat analysis was performed.

Resultados

Results: Among the 1016 patients screened, 166 were included (aspirin: 82 patients, placebo: 84). The study was interrupted early due to the higher number of adverse events in the intervention group. There was no difference in the mean deltaSOFA between groups (OR 0.60; CI 95%, -0.55 to 1.75) and no difference in any of the secondary outcomes. There were more severe adverse events in the intervention group [9 (11%) vs. 1 (1.2%), p=0.009] and more severe bleedings [7 (8,5%) vs. 1 (1.2%), p=0.03]. There was no difference in transfusions rates between the groups.

Conclusão

Conclusion: In this population of septic patients, aspirin did not reduce the intensity of organ dysfunction. Aspirin might lead to an increase in bleeding events.