ASpirin for Patients With SEPsis and SeptIc Shock

NCT01784159 | Terminated Phase 2

• 1 other identifier: EPM81449
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

Brief Summary

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 109 patients will be needed in each group. A total of 218 patients will compose the sample. 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.

Conditions

Sepsis

Keywords

ICU; Sepsis; Aspirin; Septic shock

Outcome Measures

Primary Outcomes (1)

• Difference between the Sequential Organ Failure Assessment (SOFA) Score on the seventh day of ICU stay and baseline (DeltaSOFA D7-D1).

  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. The Sequential Organ Failure Assessment (SOFA) Score ranges between 0 and 24.

  7 days

Secondary Outcomes (5)

• Mechanical ventilation free days;

  28 days

• Vasopressor free days

  28 days

• Intensive Care Unit (ICU) free days

  28 days

• Hospital free days

  28 days

• Renal replacement therapy

  28 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo 1tb / day/ 7days

Drug: Aspirin

Aspirin

ACTIVE COMPARATOR

Intervention aspirin 200 mg/day for 7 days

Drug: Aspirin

Interventions

Aspirin DRUG

Aspirin administration for 7 days

Also known as: AAS

Aspirin; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The three criteria below must be present:
• Signature of informed consent
• Patients must be older than 18 years old
• Diagnosis of sepsis and/or septic shock for less than 48 hours with at least one of the following organ dysfunctions:
• Lactate above 4mmol/L (36mg/dL)
• Thrombocytopenia \< 100,000/mm3 or reduction \> 50% in the count in the last 3 days
• PaO2/FiO2 \< 200 without signs of apparent volume overload
• Hypotension MAP \< 65mmHg refractory to volume replacement with the need to use vasopressor
• Acute renal injury increased by 2.0 to 2.9 times from baseline or diuresis rate less than 0.5ml/kg/h for more than 12 hours

You may not qualify if:

• Pregnancy
• Impossibility to use the intestinal tract
• Death perspective in less than 24 hours
• Patients in the end of their lives or in exclusive palliative care
• Patients with active bleeding
• Prior study participation
• Known allergy to aspirin
• Active peptic ulcer
• Previous use of antiplatelet agents in the last 7 days
• Previous use of AINEs in the last 7 days, except for dipyrone.
• Hemorrhagic stroke in the last 7 days or central nervous system surgery in the last 72 hours.
• Platelets \<30,000 cells/mm3.
• Large surgery in the last 24 hours if the attending surgeon judges that the risk of bleeding is high enough that aspirin cannot be used.
• Ophthalmologic surgery postoperative and transurethral resection of the prostate at the discretion of the attending physician.
• Hepatic cirrhosis or previous liver disease with altered prothrombin activity, manifested by INR above 2.0 or other previous coagulopathies.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Hospital São Paulo

São Paulo, 04024002, Brazil

Location

Related Publications (1)

• Almeida TML, Freitas FGR, Figueiredo RC, Houly SG, Azevedo LCP, Cavalcanti AB, Damiani LP, Svicero BS, Souza MA, Bustamante CLS, Ramos FJS, Alves RSV, Atallah FC, Jackiu M, Pacheco ES, Schmidt RC, Serra FSC, Tomotani DYV, Zampieri FG, Machado FR; BRICNET. Acetylsalicylic Acid Treatment in Patients With Sepsis and Septic Shock: A Phase 2, Placebo-Controlled, Randomized Clinical Trial. Crit Care Med. 2025 Feb 1;53(2):e269-e281. doi: 10.1097/CCM.0000000000006564. Epub 2025 Feb 21.

  PMID: 39982179 DERIVED

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Flavia Machado

  Federal University of São Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Intensive Care Medicine

Study Record Dates

• First Submitted: February 1, 2013
• First Posted: February 5, 2013
• Study Start: March 27, 2019
• Primary Completion: December 15, 2022
• Study Completion: January 5, 2023
• Last Updated: July 13, 2023

Record last verified: 2023-07

Locations

BR (1)