SESSION TITLE: Sepsis and Shock Posters
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 30, 2013 at 01:30 PM - 02:30 PM
PURPOSE: Azithromycin (AZ) is a macrolide used in respiratory infections that has been associated with cardiovascular (CV) deaths. Limited data are available regarding the effect of AZ in CV deaths among critically ill patients. We aimed to assess the risk of AZ-induced CV deaths and CV events in a randomized control trial (RCT) in severe septic patients.
METHODS: This open-label RCT compared azithromycin/standard of care (AZ/SOC) vs. standard of care (SOC) in patients with severe sepsis (at least one organ failure according to ACCP classification) at two tertiary teaching hospitals during a 6-year period. Intent to treat (ITT) analysis included patients that received at least one dose of AZ (total 500mg/day intravenously x5days) or one SOC medication. Exclusion criteria were allergy to macrolides, QTc prolongation >500msec and concomitant medications that prolong QT. Clinical outcomes were 30-day CV mortality and 5-day and 30-day CV events.
RESULTS: We randomized 51 subjects in the ITT analysis (n=24 in AZ/SOC vs. n=27 in SOC group). Demographic and clinical characteristics were similar among groups. 30-day CV mortality occurred in 1(4.2%) AZ/SOC subject vs. 1(3.7%) in the SOC group (p=0.93). Specific causes of CV deaths included cardiac arrest/pulseless electrical activity (PEA) (AZ/SOC Group) and cardiac arrest/PEA due to pulmonary embolism (PE) (SOC group), both on the second hospitalization day. There were no statistically significant differences in 5-day and 30-day CV events among the AZ/SOC vs. SOC groups (2[8.3%] vs. 3[11.1%], p=0.9 and 3[12.5%] vs. 3[11.1%], p=0.9, respectively). CV events in the AZ/SOC group were: atrial fibrillation (n=1, day 1), cardiac arrest/PEA (n=1, day 3) and non-sustained ventricular tachycardia (n=1, day 23). CV events in the SOC group were non-ST elevated myocardial infarction (n=2, day 1) and cardiac arrest/PEA due to PE (n=1, day 3).
CONCLUSIONS: AZ therapy in addition to SOC did not add higher 30-day CV deaths and 5-day and 30-day CV events when compared to SOC in severe septic patients.
CLINICAL IMPLICATIONS: Larger RCTs should address the safety profile of AZ among critically ill patients.
DISCLOSURE: The following authors have nothing to disclose: Paola Faverio, Alejandro Arango, A. Anzueto, Eric Mortensen, Grant Waterer, Richard Wunderink, Tim Houlihan, Clinton Ezekiel, Mauricio Jalife Bucay, Marcos Restrepo
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