This Randomized, pragmatic, multicentric with blinding of patients and health professionals,
intention-to-treat analysis has by primary endpoint to evaluate whether the aspirin use
reduces the intensity of organic dysfunction measured by the variation of the SOFA score
starting from the day of admission to the seventh day. Secundary endpoint: To evaluate if the
aspirin use reduces the time of mechanical ventilation, length of stay in the ICU and in the
hospital. In addition, to evaluate the safety of its administration regarding the occurrence
of bleeding.
The data will be collected directly from the chart of the patients admitted to the ICU.
Data quality assurance will be made through periodic verification, aiming for complete and
consistent data. The centers will receive periodic reports for adequacy of potentially
inconsistent or incomplete data.
The baseline SOFA of patients with sepsis is 8.8 with a standard deviation of 3. The expected
reduction in the control group in the SOFA at day 7 is 2 points. Considering a power of 80%
and a level of significance of 0.05, it is estimated that 143 patients will be needed in each
group. Estimating mortality up to D7 by 10%, will require 168 patients in each arm of the
study, a total of 336 patients.
All analyzes will follow the intention-to-treat principle. We will evaluate the effect of
aspirin compared to placebo on primary and binary outcomes by means of relative risks, 95%
confidence intervals and chi-square tests. For continuous outcomes with normal distribution,
we will present the mean difference, 95% confidence interval and P value calculated by t
test. For continuous outcomes with asymmetric distribution, we will perform Wilcoxon test.