Tight Sugar Blood Sugar Level Control In Seriously Sick Children Have No Special Benefits
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A team of researchers who conducted a national clinical trial found that critically ill children do not gain extra benefit from the decrease of their blood sugar level when compared to higher levels within the usual care range. Although, both levels of blood sugar control are relatively safe, control to lower levels increased the risk of a very low blood sugar (hypoglycemia) without offering a corresponding substantial benefit.
"These results complement recent findings from two important studies in related pediatric critical care populations," critical care specialist at Children's Hospital of Philadelphia (CHOP) and co-principal investigator of the study," Vinay M. Nadkarni, M.D. said.
He added that it is clear that high blood sugars are associated with worse outcomes in children but controlling blood sugar to a lower level within the usual care range does not to provide any additional advantage.
"We successfully enrolled the sickest children in ICUs across North America and were able to answer an important clinical question using the latest technology in order to mitigate risk, and arrive at a result that informs clinical practice." critical care specialist and endocrinologist at Boston Children's Hospital and lead author of the study, Michael S.D. Agus, M.D. said.
The Heart and Lung Failure Pediatric INsulin Titration Trial study (HALF-PINT) funded by the National Institutes of Health, enrolled 713 critically ill children who are between the age of 2 weeks and 17 years, from 35 different pediatric centers, according to Science Daily.
All the children had high blood glucose levels also known as hyperglycemia but none of them were cardiac surgery patients unlike previous multicenter trials. The children were randomly distributed into two groups. The researchers aimed for lower glucose control targets of 80 to 110 milligrams per deciliter in one group and a much higher target of 150 to 180 mg per deciliter in the other group.
The primary outcome was ICU-free days up to day 28 - mortality-adjusted-length of ICU stay. The HALF-PINT study is a landmark trial that pushes back against tight glycemic control medical practice amidst paradigm shifting critical care studies during the past two decades.
In 2002, two studies conducted in adult medicine reported lower morbidity and mortality rate for adult intensive care unit (ICU) patients who had tight glycemic control of 80 to 110 mg per deciliter. The findings motivated the shifting of care toward greater restrictions but subsequent multicenter adult studies discovered significant no difference between lower and higher target ranges.
Previous studies on critically ill children have offered conflicting findings. Although, retrospective research have linked high blood sugar levels with poor outcomes, two recent high impact pediatric research in cardiac surgical patients found no significant difference in survival rate and infection risk between low and high glucose target ranges, as noted by The Street.
The HALF-PINT study focused on critically ill children who do not have cardiac surgical conditions is an understudied population. The researchers found that there were no significant differences in ICU-free days, mortality, organ dysfunction or ventilator-free days in the two treatment groups.
In addition to providing no significant clinical advantage, having low target ranges within usual care increases a patient's risk of abnormally low blood sugar. The Data and Safety Monitoring Board stopped the study early, following the discovery that its continuation is highly unlikely to offer different results.
The researchers will conduct a follow-up study with the participants so as to monitor the survival and neurological outcomes, one year after treatment. They published their findings in the New England Journal of Medicine (NEJM).