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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 687-697 |
| Number of pages | 11 |
| Journal | Pediatric Critical Care Medicine |
| Volume | 23 |
| Issue number | 9 |
| DOIs | |
| State | Published - Sep 1 2022 |
Funding
Drs. Banks’, Carcillo’s, Sorenson’s, and Zimmerman’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’s, Berg’s, Newth’s, Pollack’s, Meert’s, Mourani’s, and Varni’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’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. 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.
Keywords
- corticosteroids
- health-related quality of life
- mortality
- outcomes
- septic shock
- vasoactive-inotropic support
ASJC Scopus subject areas
- Pediatrics, Perinatology, and Child Health
- Critical Care and Intensive Care Medicine