Hypoglycemia Hyperglycemia Clinical Trial
Official title:
Pediatric Critical Illness Hyperglycemia and Glycemic Control Registry: A Project to Assist in the Improved Understanding of Hyperglycemia and Glycemic Control in Pediatric Critical Illness.
The objective in this project is to assemble a consortium of pediatric critical care centers
of varying size, acuity, and composition to evaluate our glycemic control protocol on at
least 250 children with hyperglycemia in different critical care units.
***This Study is supported by an R21 Grant (MRR) from the National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK).
Many studies over the past decade have demonstrated that clinical outcomes can be improved
in critically ill adults by aggressive management of hyperglycemic with insulin infusions
(Van Den Berghe 2001, Van Den Berghe 2006, Krinsey 2004, Treggari 2008, Scalea, 2007, Lang
2007). Yet, in some of these studies and other recent trials (i.e. Glucontrol (Preiser,
2009) VISEP (Brunkhorst, 2008) and (NICE-SUGAR, 2009)), have highlighted the potential and
real risks of glycemic control (namely iatrogenic hypoglycemia) and questioned how
effectively glucose can be controlled in critical illness. One reason for the suboptimal
glycemic control witnessed in some trials may be not rigorously refined and validated. Even
as such, many medical oversight committees (including the Institutes of Healthcare
Improvement, the American Diabetes Association, and Society of Critical Care Medicine, among
others) continue to recommend regular and aggressive glycemic control in critically ill
patients. Although not specifically included nor excluded from such recommendations, most
pediatric intensivists have not incorporated glycemic control into regular practice
primarily due to concerns of therapy induced hyperglycemia - although there are reports of
protocols that appear to be effective at controlling BG levels with low rates of
hypoglycemia (Preissig et al 2008, Verhoeven et al 2009).
Our group at Emory University and Children's' Healthcare of Atlanta has taken a progressive,
yet methodical, approach to better understand the implications of hyperglycemia and its
treatment in critically ill and injured children. Practitioners at our facility developed a
pediatric-specific protocol to identify and treat hyperglycemia in critically ill children.
We have instituted this approach as standard care in our facility and have experience with
managing several hundred children with hyperglycemia. Our approach to glycemic management
has very promising safety and efficacy profiles, even when compared to the most stringent
and successful glycemic control protocols used in adults. We published the first experience
in pediatric glycemic control in pediatric in 2008 (Preissig et al PCCM 2008) and have used
our experience to identify specific risk factors for developing hypoglycemia (Preissig et al
JPed, 2009).
The goal of this proposal is to assist our step-wise approach in investigating hyperglycemia
in critically ill children by externally validating our glycemic control protocol via
multi-center evaluation. In doing so, we will also be developing the infrastructure and a
tested intervention that can be leveraged for future studies of hyperglycemia in pediatric
critical illness, including a multi-center outcome trial. The specific hypothesis for this
project is that our protocol is safe and efficient at identifying and managing hyperglycemia
in critically ill or injured children in pediatric ICUs regardless of ICU size, acuity,
model, staffing makeup, or clinical focus.
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Observational Model: Case-Only