Pediatric Intensive Care Units (ICUs) at Emory-Children's Center Glycemic Control: The PedETrol Trial
Condition: Pediatric Patient (1m-21y); ICU Admission; Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary goal of this project is to determine whether normalizing hyperglycemia is a safe
      approach to improve multisystem organ function in critically ill children requiring intensive
      care. The will are conducting the "PedETrol" (the "Pediatric ICUs at Emory-Children's Center
      Glycemic Control: The PedETrol Trial) Trial, a 4-year single-center, prospective, randomized
      clinical trial to evaluate the outcome benefit, safety and resource utilization impact of
      maintaining strict glucose control in children with life-threatening conditions.

      ***This study is supported by an Research Project Grant (RO1 grant) (MRR) via the National
      Heart, Lung, and Blood Institute (NHLBI).
    

Detailed description: 
      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.
    

Intervention name(s): Active Glycemic Control Strict (80-140mg/dL) vs. Conservative (190-220mg/dL) (with or without Continuous Glucose Monitoring)
Intervention type(s): Other
Intervention description(s): In addition to glycemic control in 2 groups, all children <1 year old and 25% of those >1 year old, will be able to receive continuous glucose monitoring via interstitial glucometry.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intensive Care; Critical care; Glycemic Control; Hypoglycemia; Hyperglycemia; Insulin treatment; Organ Function; PELOD; Outcomes; Pediatrics