Effect of aspirin on development of ARDS in at-risk patients presenting to the emergency department the LIPS-a randomized clinical trial

Daryl J. Kor, Rickey E. Carter, Pauline K. Park, Emir Festic, Valerie M. Banner-Goodspeed, Richard Hinds, Daniel Talmor, Ognjen Gajic, Lorraine B. Ware, Michelle Ng Gong

Research output: Contribution to journalArticle

78 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)2406-2414
Number of pages9
JournalJAMA - Journal of the American Medical Association
Volume315
Issue number22
DOIs
StatePublished - Jun 14 2016

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Adult Respiratory Distress Syndrome
Aspirin
Hospital Emergency Service
Randomized Controlled Trials
Length of Stay
Placebos
Intention to Treat Analysis
Lung Injury
Mechanical Ventilators
Intensive Care Units
Biomarkers
Safety
Survival
Incidence
Serum

ASJC Scopus subject areas

  • Medicine(all)

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Effect of aspirin on development of ARDS in at-risk patients presenting to the emergency department the LIPS-a randomized clinical trial. / Kor, Daryl J.; Carter, Rickey E.; Park, Pauline K.; Festic, Emir; Banner-Goodspeed, Valerie M.; Hinds, Richard; Talmor, Daniel; Gajic, Ognjen; Ware, Lorraine B.; Gong, Michelle Ng.

In: JAMA - Journal of the American Medical Association, Vol. 315, No. 22, 14.06.2016, p. 2406-2414.

Research output: Contribution to journalArticle

Kor, Daryl J. ; Carter, Rickey E. ; Park, Pauline K. ; Festic, Emir ; Banner-Goodspeed, Valerie M. ; Hinds, Richard ; Talmor, Daniel ; Gajic, Ognjen ; Ware, Lorraine B. ; Gong, Michelle Ng. / Effect of aspirin on development of ARDS in at-risk patients presenting to the emergency department the LIPS-a randomized clinical trial. In: JAMA - Journal of the American Medical Association. 2016 ; Vol. 315, No. 22. pp. 2406-2414.
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abstract = "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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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

PY - 2016/6/14

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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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