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

2014-08-27 03:13:58 | BioPortfolio

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 RO1 grant (MRR) via the National Heart, Lung, and Blood Institute (NHLBI).

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 Design

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Pediatric Patient (1m-21y)

Intervention

Active Glycemic Control Strict (80-140mg/dL) vs. Conservative (190-220mg/dL) (with or without Continuous Glucose Monitoring)

Location

Children's Healthcare of Atlanta at Egleston
Atlanta
Georgia
United States
30322

Status

Not yet recruiting

Source

Emory University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:58-0400

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PubMed Articles [13139 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

A quantitative value of a measured amount of a specific food that is equal to the GLYCEMIC INDEX of that food multiplied by the carbohydrate content of that food.

An order of fungi comprising mostly insect pathogens, though some infect mammals including humans. Strict host specificity make these fungi a focus of many biological control studies.

A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289)

A numerical system of measuring the rate of BLOOD GLUCOSE generation by a particular food item as compared to a reference item, such as glucose = 100. Foods with higher glycemic index numbers create greater blood sugar swings. These numbers do not correspond to calories or amounts of food intake but rather, depend on the rates of digestion and absorption of these food items.

An insulin preparation that is designed to provide immediate and long term glycemic control in a single dosage. Biphasic insulin typically contains a mixture of REGULAR INSULIN or SHORT-ACTING INSULIN combined with a LONG-ACTING INSULIN.

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