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Intensive insulin therapy in patients with sepsis increased risk for serious adverse events
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A new multicenter study was conducted to evaluate the effects of intensive insulin therapy in 537 patients with severe sepsis.
The researchers randomly assigned patients to intensive insulin therapy or conventional insulin therapy and 10% pentastarch or modified Ringer’s lactate for fluid resuscitation. Pentastarch, a hydroxyethyl starch, is used to prevent septic shock and increased blood volume.
The study was stopped early due to safety concerns with pentastarch, which was associated with an increased risk for acute renal failure.
After 28 days, patients assigned to intensive insulin therapy had an increased risk for severe hypoglycemia, <40 mg/dL, when compared with patients assigned to conventional insulin therapy (17% vs. 4.1%; P,.001). These patients were also at greater risk for serious adverse events (10.9% vs. 5.2%; P=.01). Intensive insulin therapy also produced lower mean morning blood glucose levels than conventional insulin therapy (112 mg/dL vs. 151 mg/dL). At study end, there were no differences in rates of mortality or organ failure between the two groups. The results of the study were published in The New England Journal of Medicine. – by Katie Kalvaitis
N Engl J Med. 2008;358:125-139.
This study was underpowered. I do not think it was very well controlled; there are a lot of defects. I do not think that hypoglycemia, which everybody is scared of, would be such a problem if the patients are carefully monitored. All of the ICU studies sort of fall through due to increased risk for hypoglycemia, and that is terrible because if you monitor the patient properly, you will not get as much hypoglycemia. In addition, none of the hypoglycemic episodes seemed to have been fatal. Also, the researchers discontinued the intensive insulin therapy before the patients were discharged from the ICU. Most ICUs, and certainly our institution, are using intensive insulin therapy by intravenous drip because all of them believe that improvements in hyperglycemia (due to diabetes or not) are important. There are obviously studies coming out that are making this controversial; this is one of them. The hypoglycemia should not be an issue. If anything, if they find an increase in mortality, then that is important. If they find increased morbidity, that can be important, but I do not consider hypoglycemia a morbidity issue. I am strongly in favor of the ICU using intensive insulin therapy. Equally important is the issue of continuing the intensive insulin therapy by some mechanism when the patient leaves the ICU, which is often a major problem in most hospitals. We are trying to introduce protocols to make it easier. Overall, I am in favor of intensive insulin therapy in the ICU and intensive diabetes therapy in the non-ICU setting.
– Derek LeRoith, MD, PhD
Endocrine Today Editorial Board member