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. 2015 Dec 3;2015(12):CD002243. doi: 10.1002/14651858.CD002243.pub3
Methods Randomized controlled trial with 2 parallel groups
2 centres
Participants Adults (n = 41) with vasopressor‐ and ventilator‐dependent septic shock
Stratification according to cortisol response to 250 µg Synacthene into non‐responders (delta cortisol ≤ 6 µg/dL) and responders (> 6 µg/dL)
Interventions
  • Hydrocortisone (100 mg intravenous bolus every 8 hours for 5 days, then tapered over 6 days)

  • Placebo


Treatments have to be initiated after 48 hours or longer from shock onset
Outcomes PRIMARY
  • Shock reversal


SECONDARY
  • 28‐Day mortality

  • ICU mortality

  • Hospital mortality

  • Improvement in haemodynamics

  • Length of stay in ICU and at hospital

  • Safety

Notes Study location: France
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated randomization scheme
Allocation concealment (selection bias) Low risk Randomization list kept confidential by the pharmacist
Blinding (performance bias and detection bias) All outcomes Low risk Participants: yes
Care‐givers: yes
Data collectors: yes
Outcome assessors: yes
Data analysts: yes
Incomplete outcome data (attrition bias) All outcomes Low risk Lost to follow‐up: none
Selective reporting (reporting bias) Low risk Access to study protocol excluding reporting bias
Other bias Low risk Full access to data excluding selection bias