Clinical impact of stress dose steroids in patients with septic shock: Insights from the PROWESS-Shock trial. Critical Care, 2015, 19: 193
Povoa, P., et al.
http://ccforum.com/content/pdf/s13054-015-0921-x.pdf
The aim of our study was to evaluate the clinical impact of the administration of intravenous
steroids, alone or in conjunction with drotrecogin-alfa (activated) (DrotAA), on the outcomes
in septic shock patients.
Methods:
We performed a sub-study of the PROWESS-Shock trial (septic shock patients who received
fluids and vasopressors above a predefined threshold for at least 4 hours were randomized to
receive either DrotAA or placebo for 96 hours). A propensity score for the administration of
intravenous steroids for septic shock at baseline was constructed using multivariable logistic
regression. Cox proportional hazards model using inverse probability of treatment weighting
of the propensity score was used to estimate the effect of intravenous steroids, alone or in
conjunction with DrotAA, on 28-day and 90-day all-cause mortality.
Results:
A total of 1695 patients were enrolled of which 49.5% received intravenous steroids for
treatment of septic shock at baseline (DrotAA + steroids N = 436; DrotAA + no steroids N =
414; placebo + steroids N = 403; placebo + no steroids N = 442). The propensity weighted
risk of 28-day as well as 90-day mortality in those treated vs. those not treated with steroids
did not differ among those randomized to DrotAA vs. placebo (interaction p-value = 0.38 and
p = 0.27, respectively) nor was a difference detected within each randomized treatment.
Similarly, the course of vasopressor use and cardiovascular SOFA did not appear to be
influenced by steroid therapy. In patients with lung infection (N = 744), abdominal infection
(N = 510), Gram-positive sepsis (N = 420) and Gram-negative sepsis (N = 461), the
propensity weighted risk of 28-day as well as 90-day mortality in those treated vs. those not
treated with steroids did not differ among those randomized to DrotAA vs. placebo
(interaction 28-day, p = 0.65, p = 0.58, p = 0.49, p = 0.12; 90-day, p = 0.75, p = 0.56, p =
0.18, p = 0.12, respectively) nor was a difference detected within each randomized treatment.
Conclusions:
In the present study of septic shock patients, after adjustment for treatment selection bias, we
were unable to find noticeable positive impact from intravenous steroids for treatment of
septic shock at baseline either in patients randomized for DrotAA or placebo.
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