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

Phase 3

Completed

• Conditions: Pediatric Patient (1m-21y); ICU Admission; Hyperglycemia
• Interventions: Other: Active Glycemic Control Strict (80-140mg/dL) vs. Conservative (190-220mg/dL) (with or without Continuous Glucose Monitoring)

• Registration Number: NCT01116752
• Lead Sponsor: Indiana University

Brief 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.

Study Timeline

• Study First Submitted: 2010-05-03
• Study First Submitted QC: 2010-05-04
• Study First Posted: 2010-05-05
• Study Start: 2010-08
• Primary Completion: 2013-12
• Status Verified: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-28
• Last Update Posted: 2015-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Strict control	Active Glycemic Control Strict (80-140mg/dL) vs. Conservative (190-220mg/dL) (with or without Continuous Glucose Monitoring)	Children requiring intensive care and mechanical ventilation and/or vasopressor/inotropic support who develop critical illness hyperglycemia (persistent BG values if \>140 mg/dL) will be randomized to have their glucose levels managed with insulin infusions and receive strict glycemic control (80-140 mg/dL)
Conservative control	Active Glycemic Control Strict (80-140mg/dL) vs. Conservative (190-220mg/dL) (with or without Continuous Glucose Monitoring)	Children requiring intensive care and mechanical ventilation and/or vasopressor/inotropic support who develop critical illness hyperglycemia (persistent BG values if \>140 mg/dL) will be randomized to have their glucose levels managed with insulin infusions and receive conservative control (190-220 mg/dL).

Primary Outcome Measures

Name	Time	Method
Determine recovery of organ function in critically ill children subject to either strict or conservative glycemic control.	8/1/2010-3/31/2014	Determine the rapidity of recovery of organ function in critically ill children subject to either strict or conservative glycemic control by assessing organ function using Pediatric Logistic Organ Dysfunction (PELOD) scoring 6 days following development of hyperglycemia.

Secondary Outcome Measures

Name	Time	Method
Adverse effect rates	8/1/2010-3/31/2014	Impact on mortality and other morbidity measures (i.e. ICU length of stay \[LOS\], mechanical ventilation days, inotrope scores, hospital acquired infections0 1) Adverse effect rates (including moderate (blood glucose \[BG\] \<60 mg/dL) and severe (BG \<40 mg/dL) hypoglycemia) associated with strict versus conservative glycemic control in pediatric critical illness.
Glycemic control compared to conservative control on care cost	8/1/2010-3/31/2014	Determine the effect of strict glycemic control compared to conservative control on care cost (i.e. hospital and ICU costs) and medical resource utilization (i.e. ICU and mechanical ventilation days) in critically ill children.

Trial Locations

Locations (1)

Children's Healthcare of Atlanta at Egleston; 🇺🇸 Atlanta, Georgia, United States