TY - JOUR
T1 - Effect of aspirin on development of ARDS in at-risk patients presenting to the emergency department the LIPS-a randomized clinical trial
AU - Kor, Daryl J.
AU - Carter, Rickey E.
AU - Park, Pauline K.
AU - Festic, Emir
AU - Banner-Goodspeed, Valerie M.
AU - Hinds, Richard
AU - Talmor, Daniel
AU - Gajic, Ognjen
AU - Ware, Lorraine B.
AU - Gong, Michelle Ng
N1 - Publisher Copyright:
© 2016 American Medical Association. All rights reserved.
PY - 2016/6/14
Y1 - 2016/6/14
N2 - Importance Management of acute respiratory distress syndrome (ARDS) remains largely supportive. Whether early intervention can prevent development of ARDS remains unclear. OBJECTIVE To evaluate the efficacy and safety of early aspirin administration for the prevention of ARDS. DESIGN, SETTING, AND PARTICIPANTS A multicenter, double-blind, placebo-controlled, randomized clinical trial conducted at 16 US academic hospitals. Between January 2, 2012, and November 17, 2014, 7673 patients at risk for ARDS (Lung Injury Prediction Score4) in the emergency department were screened and 400 were randomized. Ten patients were excluded, leaving 390 in the final modified intention-to-treat analysis cohort. INTERVENTIONS Administration of aspirin, 325-mg loading dose followed by 81mg/d (n = 195) or placebo (n = 195) within 24 hours of emergency department presentation and continued to hospital day 7, discharge, or death. MAIN OUTCOMES AND MEASURES The primary outcomewas the development of ARDS by study day 7. Secondary measures included ventilator-free days, hospital and intensive care unit length of stay, 28-day and 1-year survival, and change in serum biomarkers associated with ARDS. A final α level of.0737 (α =.10 overall) was required for statistical significance of the primary outcome. RESULTS Among 390 analyzed patients (median age, 57 years; 187 [48%] women), median (IQR) hospital length of stay was 6 (3-10) days. Administration of aspirin, compared with placebo, did not significantly reduce the incidence of ARDS at 7 days (OR, 1.24; 92.6%CI, 0.67-2.31). No significant differences were seen in secondary outcomes or adverse events.
AB - Importance Management of acute respiratory distress syndrome (ARDS) remains largely supportive. Whether early intervention can prevent development of ARDS remains unclear. OBJECTIVE To evaluate the efficacy and safety of early aspirin administration for the prevention of ARDS. DESIGN, SETTING, AND PARTICIPANTS A multicenter, double-blind, placebo-controlled, randomized clinical trial conducted at 16 US academic hospitals. Between January 2, 2012, and November 17, 2014, 7673 patients at risk for ARDS (Lung Injury Prediction Score4) in the emergency department were screened and 400 were randomized. Ten patients were excluded, leaving 390 in the final modified intention-to-treat analysis cohort. INTERVENTIONS Administration of aspirin, 325-mg loading dose followed by 81mg/d (n = 195) or placebo (n = 195) within 24 hours of emergency department presentation and continued to hospital day 7, discharge, or death. MAIN OUTCOMES AND MEASURES The primary outcomewas the development of ARDS by study day 7. Secondary measures included ventilator-free days, hospital and intensive care unit length of stay, 28-day and 1-year survival, and change in serum biomarkers associated with ARDS. A final α level of.0737 (α =.10 overall) was required for statistical significance of the primary outcome. RESULTS Among 390 analyzed patients (median age, 57 years; 187 [48%] women), median (IQR) hospital length of stay was 6 (3-10) days. Administration of aspirin, compared with placebo, did not significantly reduce the incidence of ARDS at 7 days (OR, 1.24; 92.6%CI, 0.67-2.31). No significant differences were seen in secondary outcomes or adverse events.
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U2 - 10.1001/jama.2016.6330
DO - 10.1001/jama.2016.6330
M3 - Article
C2 - 27179988
AN - SCOPUS:84974851059
SN - 0098-7484
VL - 315
SP - 2406
EP - 2414
JO - JAMA - Journal of the American Medical Association
JF - JAMA - Journal of the American Medical Association
IS - 22
ER -