Corticosteroid treatment and intensive insulin therapy for septic shock in adults: a randomized controlled trial

Annane, Djillali, Cariou, Alain, Maxime, Virginie, Azoulay, Elie, D'honneur, Gilles, Timsit, Jean Francois, Cohen, Yves, Wolf, Michel, Fartoukh, Muriel, Adrie, Christophe, Santre, Charles, Bollaert, Pierre Edouard, Mathonet, Armelle, Amathieu, Roland, Tabah, Alexis, Clec'h, Christophe, Mayaud, Julien, Lejeune, Julie and Chevret, Sylvie (2010) Corticosteroid treatment and intensive insulin therapy for septic shock in adults: a randomized controlled trial. JAMA: The Journal of the American Medical Association, 303 4: 341-348. doi:10.1001/jama.2010.2


Author Annane, Djillali
Cariou, Alain
Maxime, Virginie
Azoulay, Elie
D'honneur, Gilles
Timsit, Jean Francois
Cohen, Yves
Wolf, Michel
Fartoukh, Muriel
Adrie, Christophe
Santre, Charles
Bollaert, Pierre Edouard
Mathonet, Armelle
Amathieu, Roland
Tabah, Alexis
Clec'h, Christophe
Mayaud, Julien
Lejeune, Julie
Chevret, Sylvie
Title Corticosteroid treatment and intensive insulin therapy for septic shock in adults: a randomized controlled trial
Journal name JAMA: The Journal of the American Medical Association   Check publisher's open access policy
ISSN 0098-7484
1538-3598
Publication date 2010-01-27
Sub-type Article (original research)
DOI 10.1001/jama.2010.2
Open Access Status Not yet assessed
Volume 303
Issue 4
Start page 341
End page 348
Total pages 8
Place of publication Chicago, IL, United States
Publisher American Medical Association
Language eng
Formatted abstract
Context: Corticosteroid therapy induces potentially detrimental hyperglycemia in septic shock. In addition, the benefit of adding fludrocortisone in this setting is unclear.

Objectives: To test the efficacy of intensive insulin therapy in patients whose septic shock was treated with hydrocortisone and to assess, as a secondary objective, the benefit of fludrocortisone.

Design, Setting, and Patients: A multicenter, 2x2 factorial, randomized trial, involving 509 adults with septic shock who presented with multiple organ dysfunction, as defined by a Sequential Organ Failure Assessment score of 8 or more, and who had received hydrocortisone treatment was conducted from January 2006 to January 2009 in 11 intensive care units in France.

Interventions: Patients were randomly assigned to 1 of 4 groups: continuous intravenous insulin infusion with hydrocortisone alone, continuous intravenous insulin infusion with hydrocortisone plus fludrocortisone, conventional insulin therapy with hydrocortisone alone, or conventional insulin therapy with intravenous hydrocortisone plus fludrocortisone. Hydrocortisone was administered in a 50-mg bolus every 6 hours, and fludrocortisone was administered orally in 50-μg tablets once a day, each for 7 days.

Main Outcome Measure: In-hospital mortality.

Results: Of the 255 patients treated with intensive insulin, 117 (45.9%), and 109 of 254 (42.9%) treated with conventional insulin therapy died (relative risk [RR], 1.07; 95% confidence interval [CI], 0.88-1.30;P=.50). Patients treated with intensive insulin experienced significantly more episodes of severe hypoglycemia (<40 mg/dL) than those in the conventional-treatment group, with a difference in mean number of episodes per patient of 0.15 (95% CI, 0.02-0.28; P=.003). At hospital discharge, 105 of 245 patients treated with fludrocortisone (42.9%) died and 121 of 264 (45.8%) in the control group died (RR, 0.94; 95% CI, 0.77-1.14; P=.50).

Conclusions: Compared with conventional insulin therapy, intensive insulin therapy did not improve in-hospital mortality among patients who were treated with hydrocortisone for septic shock. The addition of oral fludrocortisone did not result in a statistically significant improvement in in-hospital mortality.

Trial Registration: Clinicaltrials.gov Identifier: NCT00320099.
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
 
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