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Core Curr: Steroids in Septic Shock NEJM 2008

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  • Figure 1. Enrollment and Outcomes.
  • Table 1. Demographic Characteristics of the Patients, According to Subgroup.
  • Table 2. Clinical Characteristics of the Patients at Baseline, According to Subgroup.
  • Figure 2. Kaplan-Meier Curves for Survival at 28 Days. For the comparison between patients with septic shock who received hydrocortisone and those who received placebo, there was no significant difference among those who did not have a response to a corticotropin test (Panel A), those who had a response to corticotropin (Panel B), and all patients who underwent evaluation (Panel C).
  • Table 3. Outcomes According to Subgroup.
  • Figure 3. Kaplan-Meier Curves for the Time to Reversal of Shock. For the comparison between patients with septic shock who received hydrocortisone and those who received placebo, P=0.06 for patients who did not have a response to a corticotropin test (Panel A) and P<0.001 both for patients who had a response to corticotropin (Panel B) and for all patients (Panel C).
  • Table 4. Adverse Events (Per-Protocol Population).

Transcript

  • 1. Original Article Hydrocortisone Therapy for Patients with Septic Shock Charles L. Sprung, M.D., Djillali Annane, M.D., Ph.D., Didier Keh, M.D., Rui Moreno, M.D., Ph.D., Mervyn Singer, M.D., F.R.C.P., Klaus Freivogel, Ph.D., Yoram G. Weiss, M.D., Julie Benbenishty, R.N., Armin Kalenka, M.D., Helmuth Forst, M.D., Ph.D., Pierre-Francois Laterre, M.D., Konrad Reinhart, M.D., Brian H. Cuthbertson, M.D., Didier Payen, M.D., Ph.D., Josef Briegel, M.D., Ph.D., for the CORTICUS Study Group N Engl J Med Volume 358(2):111-124 January 10, 2008
  • 2. In the beginning……
    • Cortisol response to corticotropin and survival in septic shock. Lancet, 1991
    • Rothwell PM , Udwadia ZF , Lawler PG . Intensive Therapy Unit, South Cleveland Hospital, Middlesbrough, UK. Corticotropin stimulation tests were used to assess adrenocortical function in 32 patients with septic shock. 13 patients had a poor cortisol response (rise less than 250 nmol/l) to corticotropin, all of whom died. However, there were only 6 deaths among the 19 patients with adequate responses (p less than 0.001). These results suggest that some patients with septic shock may have relative adrenocortical insufficiency.
  • 3. A controlled clinical trial of high-dose methylprednisolone in the treatment of severe sepsis and septic shock RC Bone, CJ Fisher, TP Clemmer, GJ Slotman, CA Metz, and RA Balk N Engl J Med Volume 317:653-658 September 10, 1987 Effect of high-dose glucocorticoid therapy on mortality in patients with clinical signs of systemic sepsis. The Veterans Administration Systemic Sepsis Cooperative Study Group
  • 4. Annane et al , JAMA 2000
    • STIM +
    • Basal <34 mg/dL
    • Stim > 9mg/dL
    • Mortality 74%
    • STIM –
    • Basal >34 mg/dL
    • Stim <9mg/dL
    • Mortality 18%
  • 5.  
  • 6. Much heterogeneity RR=1.07 (95% CI 0.91, 1.26) mortality varying regimens Systematic review of RCTs (730 patients with septic shock in 6 studies) Cronin, 1995 Introduced role of corticotropin testing - which did not predict response to steroids. 29% were adrenal insufficient (<6mcg cortisol increase after corticotropin test)    steroids: 32%   placebo: 63% (insig) Adrenal normal (n=29):   steroids 33%   placebo 64% Adrenal insufficient (n=12):   steroids 25%   placebo 63% mortality hydrocortisone 100 mg tid x5d RCT (41 patients requiring pressors >48 hrs) Bollaert, 1998 First study with sufficient power. Cotreated with fludrocortisone. 76% with adrenal insuff (<9mcg cortisol increase after corticotropin test). Overall:   steroid group 55%   placebo 61% (P =.09) Adrenal normal:   steroid group 61%   placebo 53% (P =.02) Adrenal insufficient:   steroid group 53%   placebo 63% (P =.02) mortality hydrocortisone (50 mg q 6 hrs) & fludrocortisone (50 mcg qd) RCT (300 pts, all ventilated) Annane, 2002 Comments Results Outcome measured Intervention Study design Study, year
  • 7. Study Overview
    • The benefit of adjuvant use of corticosteroids in patients with septic shock remains controversial
    • In this international, multicenter, double-blind, placebo-controlled trial, adjunctive therapy with hydrocortisone in nearly 500 patients with septic shock was not found to be clinically helpful
    • This lack of benefit was also found in a subgroup of patients who did not have a response to a corticotropin test
  • 8. Enrollment and Outcomes Sprung CL et al. N Engl J Med 2008;358:111-124
  • 9. Demographic Characteristics of the Patients, According to Subgroup Sprung CL et al. N Engl J Med 2008;358:111-124
  • 10. Clinical Characteristics of the Patients at Baseline, According to Subgroup Sprung CL et al. N Engl J Med 2008;358:111-124
  • 11. Kaplan-Meier Curves for Survival at 28 Days Sprung CL et al. N Engl J Med 2008;358:111-124
  • 12. Outcomes According to Subgroup Sprung CL et al. N Engl J Med 2008;358:111-124
  • 13. Kaplan-Meier Curves for the Time to Reversal of Shock Sprung CL et al. N Engl J Med 2008;358:111-124
  • 14. Adverse Events (Per-Protocol Population) Sprung CL et al. N Engl J Med 2008;358:111-124
  • 15. Annane et al JAMA, 2002
    • Use of Fludrocortisone
    • Overall Mortality
    • Stim results
    • Etomidate
    • Tapering steroids
  • 16. Conclusion
    • Hydrocortisone did not improve survival or reversal of shock in patients with septic shock, either overall or in patients who did not have a response to corticotropin, although hydrocortisone hastened reversal of shock in patients in whom shock was reversed