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

Keh 2003.

Methods Randomized controlled trial with cross‐over design
1 centre
Dates study was conducted: from March 1997 through September 2000
Participants Adults (n = 40) with vasopressor‐dependent septic shock
Setting: intensive care unit
Study location: Germany
Interventions
  • Hydrocortisone (100‐mg 30‐minute intravenous infusion followed by 10 mg/h continuous infusion for 3 days)

  • Placebo


All participants received hydrocortisone for 3 days preceded or followed by placebo for 3 days
Outcomes Primary
  • Immune response


Secondary
  • Improvement in haemodynamics and organ system failure

  • Safety

Notes We contacted study authors and obtained access to individual patient data
Funding sources: Deutsche Forschungsgemeinschaft (expenses for analytes) and Pharmacia/Upjohn (expenses for patients’ insurance)
Data were extracted by DA
Risk of bias was assessed by DA and BR
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
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
Other bias Low risk Full access to data including screening log