@article{1844446a88fc4d129204494a0d3898b0,
title = "The Association of Early Corticosteroid Therapy With Clinical and Health-Related Quality of Life Outcomes in Children With Septic Shock∗",
abstract = "OBJECTIVES: Corticosteroids are commonly used in the treatment of pediatric septic shock without clear evidence of the potential benefits or risks. This study examined the association of early corticosteroid therapy with patient-centered clinically meaningful outcomes. DESIGN: Subsequent cohort analysis of data derived from the prospective Life After Pediatric Sepsis Evaluation (LAPSE) investigation. Outcomes among patients receiving hydrocortisone or methylprednisolone on study day 0 or 1 were compared with those who did not use a propensity score-weighted analysis that controlled for age, sex, study site, and measures of first-day illness severity. SETTING: Twelve academic PICUs in the United States. PATIENTS: Children with community-acquired septic shock 1 month to 18 years old enrolled in LAPSE, 2013-2017. Exclusion criteria included a history of chronic corticosteroid administration. INTERVENTIONS: None. MEASUREMENTS and MAIN RESULTS: Among children enrolled in LAPSE, 352 of 392 met analysis inclusion criteria, and 155 of 352 (44%) received early corticosteroid therapy. After weighting corticosteroid therapy administration propensity across potentially confounding baseline characteristics, differences in outcomes associated with treatment were not statistically significant (adjusted effect or odds ratio [95% CI]): vasoactive-inotropic support duration (-0.37 d [-1.47 to 0.72]; p = 0.503), short-term survival without new morbidity (1.37 [0.83-2.28]; p = 0.218), new morbidity among month-1 survivors (0.70 [0.39-1.23]; p = 0.218), and persistent severe deterioration of health-related quality of life or mortality at month 1 (0.70 [0.40-1.23]; p = 0.212). CONCLUSIONS: This study examined the association of early corticosteroid therapy with mortality and morbidity among children encountering septic shock. After adjusting for variables with the potential to confound the relationship between early corticosteroid administration and clinically meaningful end points, there was no improvement in outcomes associated with this therapy. Results from this propensity analysis provide additional justification for equipoise regarding corticosteroid therapy for pediatric septic shock and ascertain the need for a well-designed clinical trial to examine benefit/risk for this intervention.",
keywords = "corticosteroids, health-related quality of life, mortality, outcomes, septic shock, vasoactive-inotropic support",
author = "{Life After Pediatric Sepsis Evaluation (LAPSE) Investigators} and Kamps, {Nicole N.} and Russell Banks and Reeder, {Ron W.} and Berg, {Robert A.} and Newth, {Christopher J.} and Pollack, {Murray M.} and Meert, {Kathleen L.} and Carcillo, {Joseph A.} and Mourani, {Peter M.} and Samuel Sorenson and Varni, {James W.} and Pelin Cengiz and Zimmerman, {Jerry J.} and Meert, {Kathleen L.} and Sabrina Heidemann and Ann Pawluszka and Melanie Lulic and Berg, {Robert A.} and Athena Zuppa and Carolann Twelves and {Ann Diliberto}, Mary and Murray Pollack and David Wessel and John Berger and Elyse Tomanio and Diane Hession and Ashley Wolfe and Peter Mourani and Todd Carpenter and Diane Ladell and Yamila Sierra and Alle Rutebemberwa and Mark Hall and Andy Yates and Lisa Steele and Maggie Flowers and Josey Hensley and Anil Sapru and Rick Harrison and Neda Ashtari and Anna Ratiu and Joe Carcillo and Michael Bell and Leighann Koch and Alan Abraham and Patrick McQuillen and Anne Mckenzie and Yensy Zetino and Christopher Newth and Thomas Shanley",
note = "Funding Information: Drs. Banks{\textquoteright}, Carcillo{\textquoteright}s, Sorenson{\textquoteright}s, and Zimmerman{\textquoteright}s institutions received funding from the National Institute of Child Health and Human Development. Drs. Banks, Reeder, Berg, Newth, Pollack, Meert, Carcillo, Mourani, Sorenson, Varni, Cengiz, and Zimmerman received support for article research from the National Institutes of Health (NIH). Drs. Reeder{\textquoteright}s, Berg{\textquoteright}s, Newth{\textquoteright}s, Pollack{\textquoteright}s, Meert{\textquoteright}s, Mourani{\textquoteright}s, and Varni{\textquoteright}s institutions received funding from the NIH. Dr. Newth received funding from Philips Research North America, Hamilton Medical, and Nihon Kohden Orange Med. Dr. Zimmerman{\textquoteright}s institution received funding from Immunexpress; he received funding from Elsevier Publishing; he disclosed the off-label product use of Corticosteroids as adjunctive treatment for pediatric septic shock. Dr. Kamps has disclosed that she does not have any potential conflicts of interest. Funding Information: This investigation was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Department of Health and Human Services, R01HD073362, and was also supported, in part, by the following cooperative agreements: UG1HD050096, UG1HD049981, UG1HD049983, UG1HD063108, UG1HD083171, UG1HD083166, UG1HD083170, U10HD050012, U10HD063106, and U01HD049934. Publisher Copyright: {\textcopyright} 2022 Lippincott Williams and Wilkins. All rights reserved.",
year = "2022",
month = sep,
day = "1",
doi = "10.1097/PCC.0000000000003009",
language = "English (US)",
volume = "23",
pages = "687--697",
journal = "Pediatric Critical Care Medicine",
issn = "1529-7535",
publisher = "Lippincott Williams and Wilkins",
number = "9",
}