The ADRENAL study protocol: adjunctive corticosteroid treatment in critically ill patients with septic shock.
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.


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.
Princess Alexandra Hospital and Wesley Hospital, University of Queensland, Brisbane, QLD, Australia. Bala_venkatesh@health.qld.gov.au
Bala
B
Venkatesh
John
J
Myburgh
Simon
S
Finfer
Steve A R
SA
Webb
Jeremy
J
Cohen
Rinaldo
R
Bellomo
Colin
C
McArthur
Christopher J
CJ
Joyce
Dorrilyn
D
Rajbhandari
Parisa
P
Glass
Meg
M
Harward
D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage; D001315:Australia / Q000453:epidemiology; D002423:Cause of Death / Q000639:trends; D016638:Critical Illness / Q000401:mortality / Q000628:therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005060:Europe / Q000453:epidemiology; D005500:Follow-Up Studies; D006801:Humans; D006854:Hydrocortisone / Q000008:administration & dosage / Q000627:therapeutic use*; D007194:India / Q000453:epidemiology; D007362:Intensive Care Units; D007902:Length of Stay / Q000639:trends; D009520:New Zealand / Q000453:epidemiology; D011446:Prospective Studies; D011788:Quality of Life; D012529:Saudi Arabia / Q000453:epidemiology; D012772:Shock, Septic / Q000188:drug therapy* / Q000401:mortality; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D006854:Hydrocortisone