SEPTIC SHOCK DOESN’T BENEFIT FROM STEROIDS

Clinical Bottom Line:

High-dose corticosteroids provides no benefit in the treatment of severe sepsis and septic shock (trend towards harmful).

Appraiser: S. Sauvé, January 24th 1993

The Evidence: Three RCTs of high-dose methylprednisolone in various stages of sepsis.

382 patients with severe sepsis (organ dysfunction) or septic shock. Solumedrol 7.25 mg/kg iv Q6H * 4.

223 patients with sepsis and normal sensorium. Solumedrol 30mg/kg bolus, 5mg/kg/hr* 9 hrs drip.

Trials Endpoints	Placebo	Tx	ARR	NNT
[1] 14 day mortality	48/190	65/191	-.09 [-.18 , .01]	-
[2] 14 day mortality	24/111	23/112	.01 [-.10 , .12]	91 (-10 -¥ + 8)
[3] hospital mortality	20/37	22/38	-.04 [-.28 , .20]	-
Overall pooled estimates Dersimonian & Laird, pooled ARR and 95% CI: -.046 [-.11 , .02] Peto, pooled odds ratio and 95% CI: 1.28 [0.92 , 1.80]

Comments:

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REFERENCES:

Bone RC, Fisher CJ, Clemmer TP, et al. A controlled clinical trial of high-dose methylprednisolone in the treatment of severe sepsis and septic shock. NEJM 1987;317:653-658.

VA Systemic Sepsis Cooperative Study Group. Effects of high-dose glucocorticoids therapy on mortality in patients with clinical signs of systemic sepsis. NEJM 1987;317:659-665.

Luce JM, Montgomery AB, Marks JD, et al. Ineffectiveness of high-dose methylprednisolone in preventing parenchymal lung injury and improving mortality in patients with septic shock. Am Rev Resp Dis 1988;138:62-68.