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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Emory University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Children's Healthcare of Atlanta
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT01116752
First received: May 3, 2010
Last updated: September 15, 2010
Last verified: May 2010
  Purpose

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).


Condition Intervention Phase
Pediatric Patient (1m-21y)
ICU Admission
Hyperglycemia
Other: Active Glycemic Control Strict (80-140mg/dL) vs. Conservative (190-220mg/dL) (with or without Continuous Glucose Monitoring)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pediatric ICUs at Emory-Children's Center Glycemic Control: The PedETrol Trial

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Determine recovery of organ function in critically ill children subject to either strict or conservative glycemic control. [ Time Frame: 8/1/2010-3/31/2014 ] [ Designated as safety issue: Yes ]
    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:
  • Adverse effect rates [ Time Frame: 8/1/2010-3/31/2014 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 8/1/2010-3/31/2014 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 1004
Study Start Date: August 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Strict control
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)
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.
Active Comparator: Conservative control
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)
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.

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.

  Eligibility

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116752

Contacts
Contact: Daniel C Keeton 404-785-6027 daniel.keeton@choa.org

Locations
United States, Georgia
Children's Healthcare of Atlanta at Egleston Recruiting
Atlanta, Georgia, United States, 30322
Contact: Daniel C Keeton, BA    404-785-6027    daniel.keeton@choa.org   
Sub-Investigator: Catherine M Pressig, MD (Co-I)         
Sub-Investigator: Kevin O Maher, MD (Co-I)         
Sub-Investigator: Traci Leong, PhD (Statistician)         
Sub-Investigator: Daniel C Keeton, BA (Coordinator)         
Sub-Investigator: Jeryl Huckaby, RRT (Coordinator)         
Principal Investigator: Mark R Rigby, MD, PhD (PI)         
Sponsors and Collaborators
Emory University
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Mark R Rigby, MD, PhD Emory University and Children's Healthcare of Atlanta at Egleston
  More Information

Publications:
Responsible Party: Mark R. Rigby, M.D., Ph.D., Emory University and Children's Healthcare of Atlanta at Egleston
ClinicalTrials.gov Identifier: NCT01116752     History of Changes
Other Study ID Numbers: Pedetrol5792, RO1
Study First Received: May 3, 2010
Last Updated: September 15, 2010
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Emory University:
Intensive Care
Critical care
Glycemic Control
Hypoglycemia
Hyperglycemia
Insulin treatment
Organ Function
PELOD
Outcomes
Pediatrics

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 28, 2014