Intensive insulin therapy and pentastarch resuscitation in severe sepsis.
نویسندگان
چکیده
BACKGROUND The role of intensive insulin therapy in patients with severe sepsis is uncertain. Fluid resuscitation improves survival among patients with septic shock, but evidence is lacking to support the choice of either crystalloids or colloids. METHODS In a multicenter, two-by-two factorial trial, we randomly assigned patients with severe sepsis to receive either intensive insulin therapy to maintain euglycemia or conventional insulin therapy and either 10% pentastarch, a low-molecular-weight hydroxyethyl starch (HES 200/0.5), or modified Ringer's lactate for fluid resuscitation. The rate of death at 28 days and the mean score for organ failure were coprimary end points. RESULTS The trial was stopped early for safety reasons. Among 537 patients who could be evaluated, the mean morning blood glucose level was lower in the intensive-therapy group (112 mg per deciliter [6.2 mmol per liter]) than in the conventional-therapy group (151 mg per deciliter [8.4 mmol per liter], P<0.001). However, at 28 days, there was no significant difference between the two groups in the rate of death or the mean score for organ failure. The rate of severe hypoglycemia (glucose level, < or = 40 mg per deciliter [2.2 mmol per liter]) was higher in the intensive-therapy group than in the conventional-therapy group (17.0% vs. 4.1%, P<0.001), as was the rate of serious adverse events (10.9% vs. 5.2%, P=0.01). HES therapy was associated with higher rates of acute renal failure and renal-replacement therapy than was Ringer's lactate. CONCLUSIONS The use of intensive insulin therapy placed critically ill patients with sepsis at increased risk for serious adverse events related to hypoglycemia. As used in this study, HES was harmful, and its toxicity increased with accumulating doses. (ClinicalTrials.gov number, NCT00135473.)
منابع مشابه
CAGS and ACS evidence based reviews in surgery. 31. The use of intensive insulin therapy and pentastarch resuscitation in patients with severe sepsis.
Question: Is the use of intensive insulin therapy compared with conventional therapy (on the basis of Leuven titration protocol) and hydroxyethyl starch (HES) compared with Ringer lactate effective and safe in patients with severe sepsis or septic shock? Design: Randomized open-label controlled trial. Setting: Multicentre (18 aca demic tertiary hospitals in Germany). Patients: Six hundred patie...
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1 Bellomo R, Bion J, Finfer S, Myburgh J, Perner A, Reinhart K. Open letter to the Executive Director of the European Medicine Agency concerning the licensing of hydroxyethyl starch solutions for fluid resuscitation. Br J Anaesth 2014; 112: 595–600 2 Brunkhorst FM, Engel C, Bloos F, et al. Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl J Med 2008; 358: 125–39 3...
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ورودعنوان ژورنال:
- The New England journal of medicine
دوره 358 2 شماره
صفحات -
تاریخ انتشار 2008