Pediatric Intensive Care Units (ICUs) at Emory-Children's Center Glycemic Control: The PedETrol Trial
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)
Links
- Source: http://clinicaltrials.gov/show/NCT01116752
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Glycemic Index
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.
Entomophthorales
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.
Metformin
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)
Patient Isolation
The segregation of patients with communicable or other diseases for a specified time. Isolation may be strict, in which movement and social contacts are limited; modified, where an effort to control specified aspects of care is made in order to prevent cross infection; or reverse, where the patient is secluded in a controlled or germ-free environment in order to protect him or her from cross infection.
Transglutaminases
Transglutaminases catalyze cross-linking of proteins at a GLUTAMINE in one chain with LYSINE in another chain. They include keratinocyte transglutaminase (TGM1 or TGK), tissue transglutaminase (TGM2 or TGC), plasma transglutaminase involved with coagulation (FACTOR XIII and FACTOR XIIIa), hair follicle transglutaminase, and prostate transglutaminase. Although structures differ, they share an active site (YGQCW) and strict CALCIUM dependence.
Clinical Trials
Strict Glycemic Control by Insulin Infusion:Observations on Emergency Department Initiation
Glycemic control can be safely achieved in surgical and medical intensive care unit settings and has been shown to improve short and long-term clinical outcomes. As such, insulin infusion...
Intensive Insulin Therapy for Strict Glycemic Control in Neurosurgical Patients: Safety and Efficacy
Strict glycemic control improves mortality and morbidity of patients admitted to the postoperative intensive care unit (ICU). The investigators would like to know if this therapy could imp...
Study of the lipid metabolism under glycemic control in septic patients who got an university 14 bed ICU. Hypothesis: establish a relationship between lipid metabolism alterations and gly...
Intraoperative Glucose Control in Liver Transplant
The goal of the proposed study is to evaluate the effectiveness of intraoperative, strict glycemic control to improve survival and infection rates following liver transplantation in a rand...
Tight Glycemic Control Increases Cardiac Stem Cells During Acute Myocardial Infarction
Objectives. The investigators analysed the effects of tight glycemic control in regenerative potential of the myocardium during acute myocardial infarction (AMI). Background. A strict gly...
PubMed Articles
Strict glycemic control needs to be maintained in critically ill surgical patients to reduce the mortality and morbidity due to hyperglycemia and associated infection. However, conventional intensive...
Dyslipidemia: a prospective controlled randomized trial of intensive glycemic control in sepsis.
PURPOSE: Metabolic disturbances are quite common in critically ill patients. Glycemic control appears to be an important adjuvant therapy in such patients. In addition, disorders...
Perkovic et al. use novel data from the ADVANCE study to report on the potential renal benefits of standard glycemic control, compared with intensive glycemic control (mean hemoglobin A 7.3 and 6.5%,...
Diabetes mellitus (DM) and congestive heart failure (HF) commonly coexist in the same patient, and the presence of DM in HF patients is associated with increased adverse events compared with patients...
Intensive insulin therapy in hospitalized patients: a systematic review.
Background: The benefits and harms of intensive insulin therapy (IIT) titrated to strict glycemic targets in hospitalized patients remain uncertain. Purpose: To evaluate the benefits and harms of IIT...
