Pediatric Critical Illness Hyperglycemia and Glycemic Control Registry

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:
NCT01116674
First received: May 3, 2010
Last updated: September 15, 2010
Last verified: May 2010
  Purpose

The objective in this project is to assemble a consortium of pediatric critical care centers of varying size, acuity, and composition to evaluate our glycemic control protocol on at least 250 children with hyperglycemia in different critical care units.

***This Study is supported by an R21 Grant (MRR) from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).


Condition
Hypoglycemia Hyperglycemia

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Pediatric Critical Illness Hyperglycemia and Glycemic Control Registry: A Project to Assist in the Improved Understanding of Hyperglycemia and Glycemic Control in Pediatric Critical Illness.

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Identify and manage hyperglycemia in pediatric intensive care unit [ Time Frame: 5-2012 ] [ Designated as safety issue: Yes ]
    Determine safety (ie hypoglycemia) and effectiveness (ie ability to establish/maintain glycemic control) of our pedatric-specific approach to control critical illness hyperglycemia.


Secondary Outcome Measures:
  • Consortium of centers practiced at glycemic control in pediatric intensive care unit. [ Time Frame: 5-2012 ] [ Designated as safety issue: Yes ]
    To develop a consortium of centers that will be practiced at glycemic control who may be able to participate in a future multi-center trial in glycemic control. To use the experience of other centers to refine a generalizable protocol to successfully and safely control hyperglycemia.


Estimated Enrollment: 250
Study Start Date: May 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Glycemic Control
Critically ill children at participating centers who require select vital organ support measure (i.e. mechanical ventilation, vasopressor, or continuous renal replacement therapy) will have routine blood glucose (BG) screening initiated (i.e. at least q 12 hours). If a patient has a BG reading of > 140 mg/dL, a repeat BG will be obtained in 1-2 hours. If this second BG is > 140 mg/dL the patient will be diagnosed with critical illness hyperglycemia and an insulin infusion will be started and BG will be maintained between 80-140 using a pediatric specific developed and tested algorithm.

Detailed Description:

Many studies over the past decade have demonstrated that clinical outcomes can be improved in critically ill adults by aggressive management of hyperglycemic with insulin infusions (Van Den Berghe 2001, Van Den Berghe 2006, Krinsey 2004, Treggari 2008, Scalea, 2007, Lang 2007). Yet, in some of these studies and other recent trials (i.e. Glucontrol (Preiser, 2009) VISEP (Brunkhorst, 2008) and (NICE-SUGAR, 2009)), have highlighted the potential and real risks of glycemic control (namely iatrogenic hypoglycemia) and questioned how effectively glucose can be controlled in critical illness. One reason for the suboptimal glycemic control witnessed in some trials may be not rigorously refined and validated. Even as such, many medical oversight committees (including the Institutes of Healthcare Improvement, the American Diabetes Association, and Society of Critical Care Medicine, among others) continue to recommend regular and aggressive glycemic control in critically ill patients. Although not specifically included nor excluded from such recommendations, most pediatric intensivists have not incorporated glycemic control into regular practice primarily due to concerns of therapy induced hyperglycemia - although there are reports of protocols that appear to be effective at controlling BG levels with low rates of hypoglycemia (Preissig et al 2008, Verhoeven et al 2009).

Our group at Emory University and Children's' Healthcare of Atlanta has taken a progressive, yet methodical, approach to better understand the implications of hyperglycemia and its treatment in critically ill and injured children. Practitioners at our facility developed a pediatric-specific protocol to identify and treat hyperglycemia in critically ill children. We have instituted this approach as standard care in our facility and have experience with managing several hundred children with hyperglycemia. Our approach to glycemic management has very promising safety and efficacy profiles, even when compared to the most stringent and successful glycemic control protocols used in adults. We published the first experience in pediatric glycemic control in pediatric in 2008 (Preissig et al PCCM 2008) and have used our experience to identify specific risk factors for developing hypoglycemia (Preissig et al JPed, 2009).

The goal of this proposal is to assist our step-wise approach in investigating hyperglycemia in critically ill children by externally validating our glycemic control protocol via multi-center evaluation. In doing so, we will also be developing the infrastructure and a tested intervention that can be leveraged for future studies of hyperglycemia in pediatric critical illness, including a multi-center outcome trial. The specific hypothesis for this project is that our protocol is safe and efficient at identifying and managing hyperglycemia in critically ill or injured children in pediatric ICUs regardless of ICU size, acuity, model, staffing makeup, or clinical focus.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Childern upto 18 or 21 years old admitted to pedaitric intensive care units who are ar risk for deleveloping critical illness hyperglycemia.

Criteria

Inclusion Criteria:

  • Critically ill children requiring mechanical ventilation, vasopressor/inotropes, continuous renal replacement therapy or other criteria, will have glycemic screening initiated. (Such are the risk factors that have been demonstrated to assist in the identification of critically children who will develop hyperglycemia (Preissig et al., JPeds., 2009)
  • Admission to the pediatric medical/surgical or pediatric cardiac intensive care unit
  • Require mechanical ventilation (endotracheal or via tracheotomy) and/or vasopressors/inotropic infusions (including dopamine, dobutamine, norepinephrine, epinephrine, vasopressin, or milrinone)
  • Patient or family member available to discuss informed consent criteria and provide informed consent.

Exclusion Criteria:

  • Patients with type I diabetes mellitus presenting to the ICU in diabetic ketoacidosis (DKA)
  • Preexisting conditions in which there is impaired glycogen stores or counter regulatory response (i.e. inborn error of metabolism, fulminant hepatic failure)
  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: NCT01116674

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

Locations
United States, Georgia
Children's Healthcare of Atlanta at Egleston - Pediatric Intensive Care Unit Recruiting
Atlanta, Georgia, United States, 30308
Contact: Daniel C Keeton, BA    404-785-6027    daniel.keeton@choa.org   
Principal Investigator: Mark R Rigby, MD, PhD         
Children's Healthcare of Atlanta at Egleston - Pediatric Cardiac Intensive Care Unit Recruiting
Atlanta, Georgia, United States, 30308
Contact: Jeryl Huckaby, RRT    404-785-0040    jeryl.huckaby@choa.org   
Principal Investigator: Kevin O Maher, MD         
Medical Center of Central Georgia - Pediatric Intensive Care Unit Recruiting
Macon, Georgia, United States, 31201
Contact: Catherine M Pressig, MD    770-653-6203    catherine.pressig@choa.org   
Principal Investigator: Catherine M Pressig, MD         
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
Study Director: Cathering M Preissig, MD (Co-I) Medical Center of Central Georgia
Study Director: Kevin O Maher, MD (Co-I) Emory University and Children's Healthcare of Atlanta at Egleston
Study Director: Daniel C Keeton, BA (Coordinator) Children's Healthcare of Atlanta at Egleston and Emory University
Study Director: Jeryl Huckaby, RRT (Coordinator) Children's Healthcare of Atlanta at Egleston and Emory University
  More Information

Publications:
Responsible Party: Mark R. Rigby, M.D., Ph.D., Emory University and Childrn's Healthcare of Atlanta at Egleston
ClinicalTrials.gov Identifier: NCT01116674     History of Changes
Other Study ID Numbers: CIH Registry, R21DK081847
Study First Received: May 3, 2010
Last Updated: September 15, 2010
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Emory University:
Intensive critical care, glycemic control, hypoglycemia, hyperglycemia , insulin treatment, intensive care outcomes, pediatrics

Additional relevant MeSH terms:
Critical Illness
Hyperglycemia
Hypoglycemia
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 26, 2014