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APROCCHSS: Difference between revisions
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Published in 2018, the Recombinant Human Activated Protein C and Low Dose of Hydrocortisone and Fludrocortisone in Adult Septic Shock (APROCCHSS) study studied over 1,200 patients with septic shock admitted to the ICU. Patients were randomized in a 2×2 factorial design to activated protein C (APC; drotrecogin alfa) or placebo, or hydrocortisone plus fludrocortisone or placebo. Once activated protein C was removed from the market, the APC arm was discontinued. The steroid regimen consisted of 7 days of hydrocortisone 60 mg IV every 6 hours and fludrocortisone 50 mcg via nasogastric tube. The steroid group showed an advantage compared to placebo in terms of the study's primary endpoint, overall survival at 90 days (43% vs. 49.1%; RR 0.88; P=0.03), as well as in secondary endpoints including time to reversal of septic shock and resolution of organ failure. | Published in 2018, the Recombinant Human Activated Protein C and Low Dose of Hydrocortisone and Fludrocortisone in Adult Septic Shock (APROCCHSS) study studied over 1,200 patients with septic shock admitted to the ICU. Patients were randomized in a 2×2 factorial design to activated protein C (APC; drotrecogin alfa) or placebo, or hydrocortisone plus fludrocortisone or placebo. Once activated protein C was removed from the market, the APC arm was discontinued. The steroid regimen consisted of 7 days of hydrocortisone 60 mg IV every 6 hours and fludrocortisone 50 mcg via nasogastric tube. The steroid group showed an advantage compared to placebo in terms of the study's primary endpoint, overall survival at 90 days (43% vs. 49.1%; RR 0.88; P=0.03), as well as in secondary endpoints including time to reversal of septic shock and resolution of organ failure. | ||
The | The survival advantage observed in this study is consistent with that seen in the [[Annane Trial]] but is discordant with other trials such as [[CORTICUS]], and may be explained in part by differences in baseline severity of illness in patients across studies. For example, patients enrolled in APROCCHSS had higher disease illness severity scores compared to those in other studies, and these more severely ill patients may stand to benefit the most from adjunctive therapies such as steroids. Additionally, APROCCHSS used combination hydrocortisone plus the mineralocorticoid fludrocortisone, whereas other trials like CORTICUS used only hydrocortisone, which may have led to a difference in efficacy between steroid regimens used across trials. | ||
Regardless of the discrepant results across studies, the cumulative trial data suggest that if steroids do in fact improve survival in septic shock, the effect is modest at best. This idea is supported by multiple meta-analyses of trials evaluating steroids in patients with septic shock.<ref>{{#pmid:29761216}}</ref><ref>{{#pmid:29979221}}</ref> The clearest role for steroids in septic shock appears to be in patients failing to improve despite adequate fluid resuscitation and vasopressor support, and this is supported by the 2016 Surviving Sepsis Campaign guidelines which were issued before APROCCHSS was published but which remain relevant today.<ref>[http://journals.lww.com/ccmjournal/Abstract/publishahead/Surviving_Sepsis_Campaign___International.96723.aspx Rhodes A, et al. "Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016." ''Critical Care Medicine.'' 2017;45(3)1-67.]</ref> | |||
==Guidelines== | ==Guidelines== | ||