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Background Hydrocortisone is widely used in patients with septic shock even though a survival benefit has been reported only in patients who remained hypotensive after fluid and vasopressor resuscitation and whose plasma cortisol levels did not rise appropriately after the administration of corticotropin.
Methods In this multicenter, randomized, double-blind, placebo-controlled trial, we assigned 251 patients to receive 50 mg of intravenous hydrocortisone and 248 patients to receive placebo every 6 hours for 5 days; the dose was then tapered during a 6-day period. At 28 days, the primary outcome was death among patients who did not have a response to a corticotropin test.
Results Of the 499 patients in the study, 233 (46.7%) did not have a response to corticotropin (125 in the hydrocortisone group and 108 in the placebo group). At 28 days, there was no significant difference in mortality between patients in the two study groups who did not have a response to corticotropin (39.2% in the hydrocortisone group and 36.1% in the placebo group, P=0.69) or between those who had a response to corticotropin (28.8% in the hydrocortisone group and 28.7% in the placebo group, P=1.00). At 28 days, 86 of 251 patients in the hydrocortisone group (34.3%) and 78 of 248 patients in the placebo group (31.5%) had died (P=0.51). In the hydrocortisone group, shock was reversed more quickly than in the placebo group. However, there were more episodes of superinfection, including new sepsis and septic shock.
Conclusions 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. (ClinicalTrials.gov number, NCT00147004
[ClinicalTrials.gov]
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Source Information
From Hadassah Hebrew University Medical Center, Jerusalem (C.L.S., Y.G.W., J. Benbenishty); Raymond Poincaré Hospital, University of Versailles, UniverSud Paris, Garches, France (D.A.); Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum, Berlin (D.K.); Hospital de St. António dos Capuchos, Centro Hospitalar de Lisboa Central, Lisbon, Portugal (R.M.); Bloomsbury Institute of Intensive Care Medicine, University College London, London (M.S.); Analytica International, Loerrach, Germany (K.F.); Klinikum Mannheim, Mannheim, Germany (A.K.); Zentralklinikum Augsburg, Augsburg, Germany (H.F.); St. Luc University Hospital, Université Catholique de Louvain, Brussels (P.-F.L.); Friedrich Schiller Universität, Jena, Germany (K.R.); Health Services Research Unit, University of Aberdeen, Aberdeen, United Kingdom (B.H.C.); Hôpital Lariboisière, Denis Diderot University of Paris, Paris (D.P.); and Klinikum der Universität, Ludwig Maximilians Universität, Munich, Germany (J. Briegel).
Address reprint requests to Dr. Sprung at the General Intensive Care Unit, Department of Anesthesiology and Critical Care Medicine, Hadassah Hebrew University Medical Center, P.O. Box 12000, Jerusalem, Israel 91120, or at sprung{at}cc.huji.ac.il.
Related Letters:
Corticosteroids for Septic Shock
Daley M. R., Seam N., Luboshitzky R., Qupti G., Bollaert P.-E., Marik P. E., Pastores S. M., Kavanagh B. P., Manoach S., Sprung C. L., Singer M., Annane D., the CORTICUS Study Group
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N Engl J Med 2008;
358:2068-2071, May 8, 2008.
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