Efficacy and safety of low-dose hydrocortisone therapy in the treatment of septic shock

Prosanto Chaudhury, John C. Marshall, Joseph S. Solomkin, N. N. Baxter, Karen Brasel, C. J. Brown, P. Chaudhury, C. S. Cutter, C. M. Divino, E. Dixon, L. Dubois, G. W N Fitzgerald, H. J A Henteleff, A. W. Kirkpatrick, S. Latosinsky, A. R. MacLean, T. M. Mastracci, R. S. McLeod, A. M. Morris, L. A. Neumayer & 2 others L. K. Temple, M. E. McKenzie

Research output: Contribution to journalArticle

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Abstract

Objective: To evaluate the efficacy and safety of low-dose hydrocortisone therapy in patients with septic shock. Design: Multicentre, randomized, double-blind, placebocontrolled trial. Setting: Nine centres (including 52 in - tensive care units) in Europe and the Middle East. Patients: Patients with clinical evidence of infection, evidence of systemic response to infection and onset of shock within the previous 72 hours (defined by systolic blood pressure <90 mm Hg despite adequate fluid replacement or a need for vasopressors for at least 1 hour) and hypo - perfusion or organ dysfunction attributable to sepsis. Intervention: Intervention group (n = 251) was randomly assigned to receive 50 mg of hydrocortisone intravenously, and the control group (n = 248) was randomly assigned to receive placebo every 6 hours for 5 days; the dose was tapered during a 6-day period. Main outcome measure: Death at 28 days in patients who did not have a response to corticotrophin. Results: In all, 233 (46.7%) patients did not have a response to corticotrophin (125 in the treatment group and 108 in the placebo group). At 28 days, there was no significant difference in mortality between patients in the 2 groups who did not have a response to corticotropin (39.2% in the treatment group and 36.1% in the placebo group, p = 0.69) or between those who had a response to corticotropin (28.8% in the treatment group and 28.7% in the placebo group, p = 1.00). At 28 days, 86 of 251 (34.3%) patients in the treatment group and 78 of 248 (31.5%) in the placebo group had died (p = 0.51). In the treatment group, shock was reversed more quickly than in the placebo group. How ever, there were more episodes of superinfection, including new sepsis and septic shock. Conclusion: Hydrocortisone cannot be recommended as general adjuvant therapy for septic shock (vasopressor responsive), nor can corticotrophin testing be recommended to determine which patients should receive hydrocortisone therapy.

Original languageEnglish (US)
Pages (from-to)415-417
Number of pages3
JournalCanadian Journal of Surgery
Volume53
Issue number6
StatePublished - Dec 2010
Externally publishedYes

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Septic Shock
Hydrocortisone
Safety
Adrenocorticotropic Hormone
Placebos
Therapeutics
Shock
Sepsis
Blood Pressure
Superinfection
Middle East
Infection
Perfusion
Outcome Assessment (Health Care)
Control Groups
Mortality

ASJC Scopus subject areas

  • Surgery

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Chaudhury, P., Marshall, J. C., Solomkin, J. S., Baxter, N. N., Brasel, K., Brown, C. J., ... McKenzie, M. E. (2010). Efficacy and safety of low-dose hydrocortisone therapy in the treatment of septic shock. Canadian Journal of Surgery, 53(6), 415-417.

Efficacy and safety of low-dose hydrocortisone therapy in the treatment of septic shock. / Chaudhury, Prosanto; Marshall, John C.; Solomkin, Joseph S.; Baxter, N. N.; Brasel, Karen; Brown, C. J.; Chaudhury, P.; Cutter, C. S.; Divino, C. M.; Dixon, E.; Dubois, L.; Fitzgerald, G. W N; Henteleff, H. J A; Kirkpatrick, A. W.; Latosinsky, S.; MacLean, A. R.; Mastracci, T. M.; McLeod, R. S.; Morris, A. M.; Neumayer, L. A.; Temple, L. K.; McKenzie, M. E.

In: Canadian Journal of Surgery, Vol. 53, No. 6, 12.2010, p. 415-417.

Research output: Contribution to journalArticle

Chaudhury, P, Marshall, JC, Solomkin, JS, Baxter, NN, Brasel, K, Brown, CJ, Chaudhury, P, Cutter, CS, Divino, CM, Dixon, E, Dubois, L, Fitzgerald, GWN, Henteleff, HJA, Kirkpatrick, AW, Latosinsky, S, MacLean, AR, Mastracci, TM, McLeod, RS, Morris, AM, Neumayer, LA, Temple, LK & McKenzie, ME 2010, 'Efficacy and safety of low-dose hydrocortisone therapy in the treatment of septic shock', Canadian Journal of Surgery, vol. 53, no. 6, pp. 415-417.
Chaudhury P, Marshall JC, Solomkin JS, Baxter NN, Brasel K, Brown CJ et al. Efficacy and safety of low-dose hydrocortisone therapy in the treatment of septic shock. Canadian Journal of Surgery. 2010 Dec;53(6):415-417.
Chaudhury, Prosanto ; Marshall, John C. ; Solomkin, Joseph S. ; Baxter, N. N. ; Brasel, Karen ; Brown, C. J. ; Chaudhury, P. ; Cutter, C. S. ; Divino, C. M. ; Dixon, E. ; Dubois, L. ; Fitzgerald, G. W N ; Henteleff, H. J A ; Kirkpatrick, A. W. ; Latosinsky, S. ; MacLean, A. R. ; Mastracci, T. M. ; McLeod, R. S. ; Morris, A. M. ; Neumayer, L. A. ; Temple, L. K. ; McKenzie, M. E. / Efficacy and safety of low-dose hydrocortisone therapy in the treatment of septic shock. In: Canadian Journal of Surgery. 2010 ; Vol. 53, No. 6. pp. 415-417.
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abstract = "Objective: To evaluate the efficacy and safety of low-dose hydrocortisone therapy in patients with septic shock. Design: Multicentre, randomized, double-blind, placebocontrolled trial. Setting: Nine centres (including 52 in - tensive care units) in Europe and the Middle East. Patients: Patients with clinical evidence of infection, evidence of systemic response to infection and onset of shock within the previous 72 hours (defined by systolic blood pressure <90 mm Hg despite adequate fluid replacement or a need for vasopressors for at least 1 hour) and hypo - perfusion or organ dysfunction attributable to sepsis. Intervention: Intervention group (n = 251) was randomly assigned to receive 50 mg of hydrocortisone intravenously, and the control group (n = 248) was randomly assigned to receive placebo every 6 hours for 5 days; the dose was tapered during a 6-day period. Main outcome measure: Death at 28 days in patients who did not have a response to corticotrophin. Results: In all, 233 (46.7{\%}) patients did not have a response to corticotrophin (125 in the treatment group and 108 in the placebo group). At 28 days, there was no significant difference in mortality between patients in the 2 groups who did not have a response to corticotropin (39.2{\%} in the treatment group and 36.1{\%} in the placebo group, p = 0.69) or between those who had a response to corticotropin (28.8{\%} in the treatment group and 28.7{\%} in the placebo group, p = 1.00). At 28 days, 86 of 251 (34.3{\%}) patients in the treatment group and 78 of 248 (31.5{\%}) in the placebo group had died (p = 0.51). In the treatment group, shock was reversed more quickly than in the placebo group. How ever, there were more episodes of superinfection, including new sepsis and septic shock. Conclusion: Hydrocortisone cannot be recommended as general adjuvant therapy for septic shock (vasopressor responsive), nor can corticotrophin testing be recommended to determine which patients should receive hydrocortisone therapy.",
author = "Prosanto Chaudhury and Marshall, {John C.} and Solomkin, {Joseph S.} and Baxter, {N. N.} and Karen Brasel and Brown, {C. J.} and P. Chaudhury and Cutter, {C. S.} and Divino, {C. M.} and E. Dixon and L. Dubois and Fitzgerald, {G. W N} and Henteleff, {H. J A} and Kirkpatrick, {A. W.} and S. Latosinsky and MacLean, {A. R.} and Mastracci, {T. M.} and McLeod, {R. S.} and Morris, {A. M.} and Neumayer, {L. A.} and Temple, {L. K.} and McKenzie, {M. E.}",
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T1 - Efficacy and safety of low-dose hydrocortisone therapy in the treatment of septic shock

AU - Chaudhury, Prosanto

AU - Marshall, John C.

AU - Solomkin, Joseph S.

AU - Baxter, N. N.

AU - Brasel, Karen

AU - Brown, C. J.

AU - Chaudhury, P.

AU - Cutter, C. S.

AU - Divino, C. M.

AU - Dixon, E.

AU - Dubois, L.

AU - Fitzgerald, G. W N

AU - Henteleff, H. J A

AU - Kirkpatrick, A. W.

AU - Latosinsky, S.

AU - MacLean, A. R.

AU - Mastracci, T. M.

AU - McLeod, R. S.

AU - Morris, A. M.

AU - Neumayer, L. A.

AU - Temple, L. K.

AU - McKenzie, M. E.

PY - 2010/12

Y1 - 2010/12

N2 - Objective: To evaluate the efficacy and safety of low-dose hydrocortisone therapy in patients with septic shock. Design: Multicentre, randomized, double-blind, placebocontrolled trial. Setting: Nine centres (including 52 in - tensive care units) in Europe and the Middle East. Patients: Patients with clinical evidence of infection, evidence of systemic response to infection and onset of shock within the previous 72 hours (defined by systolic blood pressure <90 mm Hg despite adequate fluid replacement or a need for vasopressors for at least 1 hour) and hypo - perfusion or organ dysfunction attributable to sepsis. Intervention: Intervention group (n = 251) was randomly assigned to receive 50 mg of hydrocortisone intravenously, and the control group (n = 248) was randomly assigned to receive placebo every 6 hours for 5 days; the dose was tapered during a 6-day period. Main outcome measure: Death at 28 days in patients who did not have a response to corticotrophin. Results: In all, 233 (46.7%) patients did not have a response to corticotrophin (125 in the treatment group and 108 in the placebo group). At 28 days, there was no significant difference in mortality between patients in the 2 groups who did not have a response to corticotropin (39.2% in the treatment group and 36.1% in the placebo group, p = 0.69) or between those who had a response to corticotropin (28.8% in the treatment group and 28.7% in the placebo group, p = 1.00). At 28 days, 86 of 251 (34.3%) patients in the treatment group and 78 of 248 (31.5%) in the placebo group had died (p = 0.51). In the treatment group, shock was reversed more quickly than in the placebo group. How ever, there were more episodes of superinfection, including new sepsis and septic shock. Conclusion: Hydrocortisone cannot be recommended as general adjuvant therapy for septic shock (vasopressor responsive), nor can corticotrophin testing be recommended to determine which patients should receive hydrocortisone therapy.

AB - Objective: To evaluate the efficacy and safety of low-dose hydrocortisone therapy in patients with septic shock. Design: Multicentre, randomized, double-blind, placebocontrolled trial. Setting: Nine centres (including 52 in - tensive care units) in Europe and the Middle East. Patients: Patients with clinical evidence of infection, evidence of systemic response to infection and onset of shock within the previous 72 hours (defined by systolic blood pressure <90 mm Hg despite adequate fluid replacement or a need for vasopressors for at least 1 hour) and hypo - perfusion or organ dysfunction attributable to sepsis. Intervention: Intervention group (n = 251) was randomly assigned to receive 50 mg of hydrocortisone intravenously, and the control group (n = 248) was randomly assigned to receive placebo every 6 hours for 5 days; the dose was tapered during a 6-day period. Main outcome measure: Death at 28 days in patients who did not have a response to corticotrophin. Results: In all, 233 (46.7%) patients did not have a response to corticotrophin (125 in the treatment group and 108 in the placebo group). At 28 days, there was no significant difference in mortality between patients in the 2 groups who did not have a response to corticotropin (39.2% in the treatment group and 36.1% in the placebo group, p = 0.69) or between those who had a response to corticotropin (28.8% in the treatment group and 28.7% in the placebo group, p = 1.00). At 28 days, 86 of 251 (34.3%) patients in the treatment group and 78 of 248 (31.5%) in the placebo group had died (p = 0.51). In the treatment group, shock was reversed more quickly than in the placebo group. How ever, there were more episodes of superinfection, including new sepsis and septic shock. Conclusion: Hydrocortisone cannot be recommended as general adjuvant therapy for septic shock (vasopressor responsive), nor can corticotrophin testing be recommended to determine which patients should receive hydrocortisone therapy.

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