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

Completed · Phase 3

Conditions studied: Pediatric Patient (1m-21y), ICU Admission, Hyperglycemia

In brief

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).

Key facts

Study ID

NCT01116752

Run by

Indiana University

People needed

153

Starts

2010-08-01

Expected to finish

2015-08-01

Last updated by the study team

2015-08-31

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Children's Healthcare of Atlanta at Egleston — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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