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

NCT01116752 | Completed Phase 3 DMC

• 3 other identifiers: IRB00005792RO1Pedetrol5792
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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).

Conditions

Pediatric Patient (1m-21y); ICU Admission; Hyperglycemia

Keywords

Intensive Care; Critical care; Glycemic Control; Hypoglycemia; Hyperglycemia; Insulin treatment; Organ Function; PELOD; Outcomes; Pediatrics

Outcome Measures

Primary Outcomes (1)

• Determine recovery of organ function in critically ill children subject to either strict or conservative glycemic control.

  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.

  8/1/2010-3/31/2014

Secondary Outcomes (2)

• Adverse effect rates

  8/1/2010-3/31/2014

• Glycemic control compared to conservative control on care cost

  8/1/2010-3/31/2014

Study Arms (2)

Strict control

ACTIVE COMPARATOR

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)

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

Conservative control

ACTIVE COMPARATOR

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).

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

Interventions

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

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.

Conservative control; Strict control

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Indiana University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Children's Healthcare of Atlanta: collaborator

Study Sites (1)

Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, 30322, United States

Location

Related Publications (5)

• Preissig CM, Rigby MR, Maher KO. Glycemic control for postoperative pediatric cardiac patients. Pediatr Cardiol. 2009 Nov;30(8):1098-104. doi: 10.1007/s00246-009-9512-4. Epub 2009 Aug 25.

  PMID: 19705188 BACKGROUND

• Preissig CM, Rigby MR. Pediatric critical illness hyperglycemia: risk factors associated with development and severity of hyperglycemia in critically ill children. J Pediatr. 2009 Nov;155(5):734-9. doi: 10.1016/j.jpeds.2009.05.007. Epub 2009 Jul 22.

  PMID: 19628220 BACKGROUND

• Preissig CM, Rigby MR. A disparity between physician attitudes and practice regarding hyperglycemia in pediatric intensive care units in the United States: a survey on actual practice habits. Crit Care. 2010;14(1):R11. doi: 10.1186/cc8865. Epub 2010 Feb 3.

  PMID: 20128893 BACKGROUND

• Vlasselaers D, Milants I, Desmet L, Wouters PJ, Vanhorebeek I, van den Heuvel I, Mesotten D, Casaer MP, Meyfroidt G, Ingels C, Muller J, Van Cromphaut S, Schetz M, Van den Berghe G. Intensive insulin therapy for patients in paediatric intensive care: a prospective, randomised controlled study. Lancet. 2009 Feb 14;373(9663):547-56. doi: 10.1016/S0140-6736(09)60044-1. Epub 2009 Jan 26.

  PMID: 19176240 BACKGROUND

• Preissig CM, Hansen I, Roerig PL, Rigby MR. A protocolized approach to identify and manage hyperglycemia in a pediatric critical care unit. Pediatr Crit Care Med. 2008 Nov;9(6):581-8. doi: 10.1097/PCC.0b013e31818d36cb.

  PMID: 18838924 BACKGROUND

MeSH Terms

Conditions

Hyperglycemia; Hypoglycemia

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Mark R Rigby, MD, PhD

  Emory University and Children's Healthcare of Atlanta at Egleston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 5, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: August 1, 2015
• Last Updated: August 31, 2015

Record last verified: 2015-08

Locations

US (1)