25 Jan Low Glucose Target in Critically Ill Children May Be Counterproductive
MedicalResearch.com Interview with:
Dr. Michael Agus MD
Pediatric critical care specialist and endocrinologist
Boston Children’s Hospital and Harvard Medical School and
Dr. Vinay Nadkarni, MD
Pediatric critical care specialist
Children’s Hospital of Philadelphia and
University of Pennsylvania School of Medicine
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Controlling the blood sugar of a critically ill child while sick in the ICU has been the matter of much debate since the first trial appeared in 2001 suggesting there was substantial benefit in certain adult populations. Retrospective data in adults and children consistently and convincingly associate hyperglycemia with poor outcomes across a wide range endpoints, however, the question remains whether normalizing glucose levels changes those outcomes. As the data emerged from prospective trials specifically in children, the answer became less clear.
We performed a large study of glucose control in critically ill children who had not had cardiac surgery, as this was group in which questions about best practice lingered.
Our study showed that critically ill infants and children do not gain additional benefit from controlling their elevated blood sugars down to a lower target range of 80-110 mg/dL compared to a higher target range of 150-180 mg/dL. Patients treated in both target ranges had similar outcomes in virtually every parameter studied, including the primary outcome of ICU-free days up to day 28 (mortality-adjusted length of ICU stay), where both groups had the same number at 19.4 days. There were differences in severe hypoglycemia (<40 mg/dL) related to the protocol where those with the lower target range had a rate of 3.7% compared to 0.3% in the higher target range, and an increased rate of catheter-associated bloodstream infections (CABSI’s) was noted in the lower target range with 1.94 infections per 1,000 catheter days compared with none in the higher target range.
On the other hand, empiric antibiotic use was significantly higher in the higher target range, at 96.8%, compared with 93.4% in the lower target range. No other intergroup differences were detected in mortality, severity of illness, seizures, or the need for CPR, ECMO, renal replacement therapy or transfusion.
MedicalResearch.com: What should readers take away from your report?
Response: We have shown that in this population of particularly sick critically ill children across 32 North American ICUs, controlling blood glucose to a lower target range of 80-100 mg/dL confers no benefit compared with a higher target range of 150-180 mg/dL, and is associated with the possibility of increased harm.
MedicalResearch.com: Is there anything else you would like to add?
Response: The study was halted by independent Data and Safety Monitoring Board when the study was at 50% enrollment due to a conditional power analysis which suggested a 1% chance of showing that the lower target range was beneficial, in combination with increased rates of severe hypoglycemia and CABSI’s in the lower target range.
The study was funded by grants from the National Heart, Lung, and Blood Institute, National Institutes of Health. Discounted or free devices were provided to the investigator-initiated trial by Nova Biomedical, Dexcom, Medtronic Minimed, and Edwards Scientific. None of the companies participated in trial design, data analysis, or manuscript preparation.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Citation:
Tight Glycemic Control in Critically Ill Children
January 24, 2017DOI: 10.1056/NEJMoa1612348
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.
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Last Updated on January 25, 2017 by Marie Benz MD FAAD