Corticosteroid treatment and intensive insulin therapy for septic shock in adults: a randomized controlled trial
- PMID: 20103758
- DOI: 10.1001/jama.2010.2
Corticosteroid treatment and intensive insulin therapy for septic shock in adults: a randomized controlled trial
Erratum in
- JAMA. 2010 May 5;303(17):1698
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, 2 x 2 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-microg 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.
Comment in
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Should glucocorticoid-induced hyperglycemia be treated in patients with septic shock?JAMA. 2010 Jan 27;303(4):365-6. doi: 10.1001/jama.2010.41. JAMA. 2010. PMID: 20103763 No abstract available.
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Tight glycemic control in critically ill patients.JAMA. 2010 May 5;303(17):1694; author reply 1694-5. doi: 10.1001/jama.2010.515. JAMA. 2010. PMID: 20442380 No abstract available.
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ACP Journal Club. Intensive insulin therapy did not reduce mortality more than conventional therapy in septic shock treated with corticosteroids.Ann Intern Med. 2010 May 18;152(10):JC5-5. doi: 10.7326/0003-4819-152-10-201005180-02005. Ann Intern Med. 2010. PMID: 20479022 No abstract available.
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