Pediatric Critical Illness Hyperglycemia and Glycemic Control Registry

NCT01116674 | Completed DMC

• 3 other identifiers: IRB00045186R21DK081847CIH Registry
• Study Type: observational
• Target: 206
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Hypoglycemia Hyperglycemia

Keywords

Intensive critical care, glycemic control, hypoglycemia, hyperglycemia , insulin treatment, intensive care outcomes, pediatrics

Outcome Measures

Primary Outcomes (1)

• Identify and manage hyperglycemia in pediatric intensive care unit

  Determine safety (ie hypoglycemia) and effectiveness (ie ability to establish/maintain glycemic control) of our pedatric-specific approach to control critical illness hyperglycemia.

  5-2012

Secondary Outcomes (1)

• Consortium of centers practiced at glycemic control in pediatric intensive care unit.

  5-2012

Study Arms (1)

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.

Eligibility Criteria

• Age: 1 Day - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Indiana University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Children's Healthcare of Atlanta: collaborator

Study Sites (3)

Children's Healthcare of Atlanta at Egleston - Pediatric Cardiac Intensive Care Unit

Atlanta, Georgia, 30308, United States

Location

Children's Healthcare of Atlanta at Egleston - Pediatric Intensive Care Unit

Atlanta, Georgia, 30308, United States

Location

Medical Center of Central Georgia - Pediatric Intensive Care Unit

Macon, Georgia, 31201, United States

Location

Related Publications (4)

• 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

• 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

Hypoglycemia; Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mark R Rigby, MD, PhD

  Emory University and Children's Healthcare of Atlanta at Egleston

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 5, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: August 31, 2015

Record last verified: 2015-08

Locations

US (3)