BACKGROUND: There is considerable global uncertainty on the role of low-dose corticosteroids in septic shock, which translates into variations in prescribing practices. OBJECTIVE: To describe the protocol for a large-scale multicentre randomised controlled trial in critically ill patients with septic shock, comparing the effects of hydrocortisone and placebo (in addition to standard treatment) on 90-day mortality and other outcomes such as shock reversal, duration of mechanical ventilation and quality of life. METHODS: We will recruit 3800 critically ill patients with septic shock treated in an intensive care unit, to concealed, randomised, parallel assignment of hydrocortisone or placebo. The primary outcome will be all-cause mortality at 90 days postrandomisation. Secondary outcomes will include ICU and hospital mortality, length of ICU stay and quality of life at 6 months. Subgroup analyses will be conducted in two predefined subgroups. All analyses will be conducted on an intention-to-treat basis. RESULTS AND CONCLUSIONS: The run-in phase has been completed and the main trial commenced in February 2013. The trial should generate results that will inform and influence prescribing of corticosteroids in septic shock.
RCT Entities:
BACKGROUND: There is considerable global uncertainty on the role of low-dose corticosteroids in septic shock, which translates into variations in prescribing practices. OBJECTIVE: To describe the protocol for a large-scale multicentre randomised controlled trial in critically illpatients with septic shock, comparing the effects of hydrocortisone and placebo (in addition to standard treatment) on 90-day mortality and other outcomes such as shock reversal, duration of mechanical ventilation and quality of life. METHODS: We will recruit 3800 critically illpatients with septic shock treated in an intensive care unit, to concealed, randomised, parallel assignment of hydrocortisone or placebo. The primary outcome will be all-cause mortality at 90 days postrandomisation. Secondary outcomes will include ICU and hospital mortality, length of ICU stay and quality of life at 6 months. Subgroup analyses will be conducted in two predefined subgroups. All analyses will be conducted on an intention-to-treat basis. RESULTS AND CONCLUSIONS: The run-in phase has been completed and the main trial commenced in February 2013. The trial should generate results that will inform and influence prescribing of corticosteroids in septic shock.
Authors: Anders Perner; Anthony C Gordon; Derek C Angus; Francois Lamontagne; Flavia Machado; James A Russell; Jean-Francois Timsit; John C Marshall; John Myburgh; Manu Shankar-Hari; Mervyn Singer Journal: Intensive Care Med Date: 2017-05-12 Impact factor: 17.440
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Authors: Anders Perner; Andrew Rhodes; Bala Venkatesh; Derek C Angus; Ignacio Martin-Loeches; Jean-Charles Preiser; Jean-Louis Vincent; John Marshall; Konrad Reinhart; Michael Joannidis; Steven M Opal Journal: Intensive Care Med Date: 2017-01-27 Impact factor: 17.440
Authors: Allan Doctor; Jerry Zimmerman; Michael Agus; Surender Rajasekaran; Juliane Bubeck Wardenburg; James Fortenberry; Anne Zajicek; Emma Mairson; Katri Typpo Journal: Pediatr Crit Care Med Date: 2017-03 Impact factor: 3.624
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