Safe and effective use of aspirin in intensive care patients.

Phase 1

• Conditions: Sepsis; Infection - Other infectious diseases; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12611000649910
• Lead Sponsor: Royal Melbourne Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

Ninety critically ill adult patients over 18 years of age with SIRS or sepsis (infected site plus SIRS) will be enrolled having given informed consent. Study subjects will be required to have not taken aspirin in the 6 weeks prior to admission to ICU. An untreated control population consisting of 45 patients with SIRS or sepsis that are not treated with aspirin will be recruited and blood samples will be drawn to allow comparison of changes in PD parameters with aspirin treated patients.

Exclusion Criteria

Patients with a contraindication to aspirin due to hypersensitivity to aspirin or NSAID drugs
platelet count <100,000×109/l
coagulopathy with INR>2 or active bleeding (eg, trauma, gastrointestinal or intracranial bleeding) will be excluded. Patients with pre-existing renal injury as per RIFLE guidelines will be excluded.
Patients will have study medications ceased if there is evidence of hypersensitivity to aspirin (new onset of severe bronchospasm or urticarial rash), renal injury (serum creatinine doubling / GFR reducing by > 50%) or new onset of bleeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic and pharmacodynamic (PK/PD) modelling of the acetylsalicylic acid (ASA) and salicylic acid (SA) concentrations in SIRS/septic patients and relating them to their effect on immunological pathways caused by aspirin-triggered lipoxins (ATL) and NF-kappaB.[Ten mL of arterial blood will be taken immediately before (T 0) the first dose of aspirin (or at T0 in control patients not treated with aspirin) and after 1 hour (T 1), T 1.5, T 4, T 8, T 24, T 32, T 48.]

Secondary Outcome Measures

Name	Time	Method
Assessment of trends in clinical outcomes shown by sequential organ failure assessment (SOFA) score reductions in treated compared with control populations.[Daily measures for 2 days during study period.];Comparison of safety as measured by new onset bleeding or renal injury among aspirin and untreated disease controls in ICU patients with sepsis.[Continuous clinical observation during ICU stay for study period and further 3 days for new onset bleeding. Daily measure of urea and electrolytes for renal injury (increase by greater than factor of two in baseline creatinine) during study period.]