Pediatric Intensive Care Units (ICUs) at Emory-Children's Center Glycemic Control: The PedETrol Trial

Many reports demonstrate improved outcomes in critically ill adults who develop
hyperglycemia by rigorous glycemic. Medical oversight committees (including the Institutes
of Healthcare Improvement, the American Diabetes Association, and Society of Critical Care
Medicine, among others) recommend routine glycemic control during critical illness. Some
studies show high rates of hypoglycemia and have highlighted the concern of this approach to
care. Little data exists on how hyperglycemia and glycemic control affects critically ill
children. Our practice group has developed a regular approach to glycemic control that
appears effective and safe and controlling hyperglycemia and the investigators believe that
due to our unique experience and expertise in this field, the investigators are well-poised
to conduct further much needed studies regarding glycemic control in children. To
specifically address the void of knowledge regarding glycemic control in critically ill
children, the investigators will conduct a single-center randomized controlled trial to
ascertain whether there is vital organ system, outcome, and resource utilization benefit to
strict glycemic control vs. more conservative control in children requiring intensive care.
The "PedETrol" (the "Pediatric ICUs at Emory-Children's Center Glycemic Control) Trial will
study 1,004 children admitted to the ICU for medical, surgical, or cardiac conditions
requiring mechanical ventilation and/or vasopressor/i support who develop hyperglycemia,
defined as persistent blood glucose >140 mg/dL). Participants will be randomized to either
receive strict glycemic control (80-140 mg/dL) or more conservative control (190-220 mg/dL).
Insulin infusions will be used to maintain blood glucose in these ranges. In addition to
assessing organ and outcome specific efficacy parameters, the investigators will
meticulously evaluate for untoward effects including hypoglycemia, and determine the impact
of this practice on costly medical resources. All children <1 year old and 25% of those >1
year old, will be able to receive continuous glucose monitoring via interstitial glucometry.
This appears to be the first glycemic control trial in any critical care population to make
use of continuous glucose monitoring.

Inclusion Criteria:

- Critically ill children with hyperglycemia, defined as persistent BG >140 mg/dL,
meeting the following criteria will be targeted for this study.

- Age 1 month -18 years old

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

- Require mechanical ventilation and/or vasopressors/inotropic infusions

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

Exclusion Criteria:

- Age >18 years old

- Age <1 month of chronologic age

- Patients with type I diabetes mellitus or other conditions in which there is impaired
glycogen stores or counter regulatory response (i.e. inborn error of metabolism,
fulminant hepatic failure)

- Patients with "do not resuscitate", "do not intubate", or "do not escalate care"
orders

- Lack of availability by parent or legal guardian to assist in the consent process
will be excluded