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Pediatric Critical Illness Hyperglycemia and Glycemic Control Registry

28 augustus 2015 bijgewerkt door: Indiana University

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.

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).

Studie Overzicht

Toestand

Voltooid

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

206

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Georgia
      • Atlanta, Georgia, Verenigde Staten, 30308
        • Children's Healthcare of Atlanta at Egleston - Pediatric Cardiac Intensive Care Unit
      • Atlanta, Georgia, Verenigde Staten, 30308
        • Children's Healthcare of Atlanta at Egleston - Pediatric Intensive Care Unit
      • Macon, Georgia, Verenigde Staten, 31201
        • Medical Center of Central Georgia - Pediatric Intensive Care Unit

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

1 dag tot 21 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Identify and manage hyperglycemia in pediatric intensive care unit
Tijdsspanne: 5-2012
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Consortium of centers practiced at glycemic control in pediatric intensive care unit.
Tijdsspanne: 5-2012
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.
5-2012

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Mark R Rigby, MD, PhD, Emory University and Children's Healthcare of Atlanta at Egleston
  • Studie directeur: Cathering M Preissig, MD (Co-I), Medical Center of Central Georgia
  • Studie directeur: Kevin O Maher, MD (Co-I), Emory University and Children's Healthcare of Atlanta at Egleston
  • Studie directeur: Daniel C Keeton, BA (Coordinator), Children's Healthcare of Atlanta at Egleston and Emory University
  • Studie directeur: Jeryl Huckaby, RRT (Coordinator), Children's Healthcare of Atlanta at Egleston and Emory University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 mei 2010

Primaire voltooiing (Werkelijk)

1 december 2013

Studie voltooiing (Werkelijk)

1 december 2014

Studieregistratiedata

Eerst ingediend

3 mei 2010

Eerst ingediend dat voldeed aan de QC-criteria

3 mei 2010

Eerst geplaatst (Schatting)

5 mei 2010

Updates van studierecords

Laatste update geplaatst (Schatting)

31 augustus 2015

Laatste update ingediend die voldeed aan QC-criteria

28 augustus 2015

Laatst geverifieerd

1 augustus 2015

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • IRB00045186
  • R21DK081847 (Subsidie/contract van de Amerikaanse NIH)
  • CIH Registry (Andere identificatie: Other)

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