Methodology Score: 4/5
Usefulness Score: 3/5
Journal Club Bottom Line
Question/Methods: This was a international, pragmatic, double-blind, randomized, controlled trial comparing hydrocortisone as continuous infusion to placebo in patients with septic shock on mechanical ventilation and at least 4-hours of vasopressor support in ICU.
Findings: There were no significant between-group differences at 90-days with respect to mortality, the shock recurrence, re-intubation, renal-replacement therapy, or new-onset bacteremia or fungemia. Hydrocortisone group had a faster shock resolution of shock, shorter time to ICU discharge and received fewer blood transfusions.
Interpretation: Among patients with septic shock on mechanical ventilation, hydrocortisone infusion did not result in lower 90-day mortality. Given the positive secondary outcomes and current guideline recommendations, clinicians should continue to use steroids in septic shock.
A random allocation of patients to treatment-control group (by sealed envelopes etc.) generally leads to balanced groups but can lead to differences in the groups on some aspects (more males or obese patients in one arm than the other). If important factors are identified (e.g. sex, obesity) then the patients could be stratified based on sex and BMI. Using block randomization, a list is created for a block of x patients to be equally assigned to the study arms based on the important factors identified. If there a large number of important factors, then the block randomization becomes extremely complex. Adaptive stratified sampling algorithm can be used to calculate the imbalance between the groups based on each factor and add an additional random element to assignment of the next patient.