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APROCCHSS: Difference between revisions
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Multiple RCTs have investigated the potential role for steroid therapy in patients with septic shock. The [[Annane Trial]] in 2002 with 299 patients demonstrated a short-term mortality benefit with IV hydrocortisone and fludrocortisone among patients with evidence of adrenal insufficiency on ACTH stimulation testing. [[CORTICUS]] with 499 patients in 2008 investigated hydrocortisone in patients with and without adrenal insufficiency and found a faster reversal of shock but no benefit in either subgroup with suggestion of increased infection rates in patients receiving hydrocortisone. [[HYPRESS]] in 2016 with 380 patients showed no difference in mortality but showed decrease time to reversal of shock. In the same edition of the journal but selected to be epublished ahead of print, the [[ADRENAL]] trial included 3800, demonstrated no difference in 90 day mortality. | Multiple RCTs have investigated the potential role for steroid therapy in patients with septic shock. The [[Annane Trial]] in 2002 with 299 patients demonstrated a short-term mortality benefit with IV hydrocortisone and fludrocortisone among patients with evidence of adrenal insufficiency on ACTH stimulation testing. [[CORTICUS]] with 499 patients in 2008 investigated hydrocortisone in patients with and without adrenal insufficiency and found a faster reversal of shock but no benefit in either subgroup with suggestion of increased infection rates in patients receiving hydrocortisone. [[HYPRESS]] in 2016 with 380 patients showed no difference in mortality but showed decrease time to reversal of shock. In the same edition of the journal but selected to be epublished ahead of print, the [[ADRENAL]] trial included 3800, demonstrated no difference in 90 day mortality. | ||
Published in 2018, the Hydrocortisone plus Fludrocortisone for Adults with Septic Shock, was the reporting of the steroid vs. placebo parallel arm of the Activated Protein C and Corticosteroids for Human Septic Shock (APROCCHSS) trial <ref>{{#pmid:23525934}}</ref>. After withdrawal of activated protein C from the market, that arm was suspended and analyzed to show no statistical difference with activated protein C on mortality nor interaction with the low-dose steroids. | Published in 2018, the Hydrocortisone plus Fludrocortisone for Adults with Septic Shock, was the reporting of the steroid vs. placebo parallel arm of the Activated Protein C and Corticosteroids for Human Septic Shock (APROCCHSS) trial <ref name=APC>{{#pmid:23525934}}</ref>. After withdrawal of activated protein C from the market, that arm was suspended and analyzed to show no statistical difference with activated protein C on mortality nor interaction with the low-dose steroids. | ||
the Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock (ADRENAL) trial randomized 3800 patients from 69 international sites with septic shock on vasopressors and mechanical ventilation to hydrocortisone 200 mg/day continuous infusion or placebo. There was no difference at the primary outcome of death from any cause at 90 days, nor were any difference found in any of the six prespecified subgroups. The hydrocortisone group had faster time to reversal of shock, shorter time to discharge from the ICU, time to extubation, and decreased number of blood transfusion. These additional outcomes may best be regarded as hypothesis-generating. | the Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock (ADRENAL) trial randomized 3800 patients from 69 international sites with septic shock on vasopressors and mechanical ventilation to hydrocortisone 200 mg/day continuous infusion or placebo. There was no difference at the primary outcome of death from any cause at 90 days, nor were any difference found in any of the six prespecified subgroups. The hydrocortisone group had faster time to reversal of shock, shorter time to discharge from the ICU, time to extubation, and decreased number of blood transfusion. These additional outcomes may best be regarded as hypothesis-generating. | ||