Impact of aspirin in organ dysfunction severity in patients with sepsis and septic shock: a randomized, double blinded, placebo-controlled trial - Aspirin for Patients with Sepsis (AsP Sepsis)

• Grant number: 20/02261-0
• Support Opportunities: Regular Research Grants
• Start date: April 01, 2021
• End date: March 31, 2023
• Field of knowledge: Health Sciences - Medicine - Medical Clinics
• Principal Investigator: Flavia Ribeiro Machado
• Grantee: Flavia Ribeiro Machado
• Host Institution: Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil
• Associated researchers: Alexandre Biasi Cavalcanti ; Fernando Godinho Zampieri ; Flávio Geraldo Rezende de Freitas ; Luciano Cesar Pontes de Azevedo

Abstract

Platelets activation is a key factor in the genesis of microthrombosis, an important feature of infectious diseases. This microthrombosis may contribute for organ dysfunction progression during sepsis. Several drugs were tested aiming to regulate coagulation. However, there is a notable paucity of papers on the use of aspirin in sepsis. Observational studies have shown an association between prior use of aspirin and reduction of sepsis morbidity and mortality. However, there are no randomized prospective studies testing this intervention in septic patients. The objectives of this study are to evaluate the impact of aspirin use in sepsis-related organ dysfunction, assessed by differences in SOFA score from day 0 to day 7, and to evaluate its effect on length of mechanical ventilation, length of vasopressor use, renal function, ICU and hospital length of stay, as well as safety outcomes such as the occurrence of bleeding. Thus, adult patients with a diagnosis of sepsis and/or septic shock for less than 48 hours will be randomized and allocated to 2 groups. Group 1 will receive 200 mg of aspirin and Group 2 will receive placebo, both once daily for 7 days, in a blinded fashion. All patients will be evaluated at baseline (D0), and their demographic characteristics, infectious profile and severity are applied by the SAPS3 and SOFA scores. Primary outcome will be the difference between SOFA at baseline and Day 7. (AU)