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. 2015 Dec 3;2015(12):CD002243. doi: 10.1002/14651858.CD002243.pub3
Methods Randomized controlled trial
10 centres
Participants Adults (n = 223) with sepsis or septic shock (n = 100)
Interventions
  • Methylprednisolone (30 mg/kg as a single intravenous 10 to 15‐minute infusion, followed by a constant infusion of 5 mg/kg/h for 9 hours)

  • Placebo


Treatment had to be initiated within 2 hours
Outcomes PRIMARY
  • 14‐Day mortality


SECONDARY
  • Complications

Notes Study location: USA
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 Centralized randomization
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) Unclear risk No access to study protocol
Other bias Unclear risk No data to exclude selection bias