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Pediatric Critical Illness Hyperglycemia and Glycemic Control Registry

28. august 2015 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

206

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 dag til 21 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Identify and manage hyperglycemia in pediatric intensive care unit
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Consortium of centers practiced at glycemic control in pediatric intensive care unit.
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2010

Primær færdiggørelse (Faktiske)

1. december 2013

Studieafslutning (Faktiske)

1. december 2014

Datoer for studieregistrering

Først indsendt

3. maj 2010

Først indsendt, der opfyldte QC-kriterier

3. maj 2010

Først opslået (Skøn)

5. maj 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

31. august 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. august 2015

Sidst verificeret

1. august 2015

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • IRB00045186
  • R21DK081847 (U.S. NIH-bevilling/kontrakt)
  • CIH Registry (Anden identifikator: Other)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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