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. 2019 Dec 6;2019(12):CD002243. doi: 10.1002/14651858.CD002243.pub4

Hyvernat 2016.

Methods Randomized controlled trial with 2 parallel groups
4 centres
Dates study was conducted: from November 2008 through June 2010
Participants Adults (n = 120) with septic shock
Subgroups based on adrenal status assessed by a 250‐µg ACTH test
Setting: intensive care unit
Study location: France
Interventions
  • Hydrocortisone 50 mg intravenous bolus every 6 hours for 5 days without tapering

  • Hydrocortisone as an initial bolus of 100 mg followed by continuous infusion of 300 mg per day for 5 days without tapering

Outcomes Primary
  • 28‐Day all‐cause mortality


Secondary
  • Time

  • Days free of vasopressor (with zero days assigned to participants dying before being weaned off)

  • Days free of mechanical ventilation (with zero days assigned to participants dying before being weaned off)

  • Days free of renal replacement therapy (with zero days assigned to participants dying before being weaned off)

  • Safety

Notes We contacted study authors and obtained access to individual patient data
Fundng source: Association Niçoise de Réanimation Médicale
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
Caregivers: 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 No evidence of other bias