Pediatric Critical Illness Hyperglycemia and Glycemic Control Registry

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.

Inclusion Criteria:

- Critically ill children requiring mechanical ventilation, vasopressor/inotropes,
continuous renal replacement therapy or other criteria, will have glycemic screening
initiated. (Such are the risk factors that have been demonstrated to assist in the
identification of critically children who will develop hyperglycemia (Preissig et
al., JPeds., 2009)

- Admission to the pediatric medical/surgical or pediatric cardiac intensive care unit

- Require mechanical ventilation (endotracheal or via tracheotomy) and/or
vasopressors/inotropic infusions (including dopamine, dobutamine, norepinephrine,
epinephrine, vasopressin, or milrinone)

- Patient or family member available to discuss informed consent criteria and provide
informed consent.

Exclusion Criteria:

- Patients with type I diabetes mellitus presenting to the ICU in diabetic ketoacidosis
(DKA)

- Preexisting conditions in which there is impaired glycogen stores or counter
regulatory response (i.e. inborn error of metabolism, fulminant hepatic failure)