Hypoglycemia HyperglycemiaNCT01116674
Pediatric Critical Illness Hyperglycemia and Glycemic Control Registry
An observational study of Hypoglycemia Hyperglycemia, run by Indiana University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 21 years
- Conditions the study is for
- Hypoglycemia Hyperglycemia
- Type of treatment
- Injection or infusion
- How many people
- 206 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2010to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Childern upto 18 or 21 years old admitted to pedaitric intensive care units who are ar risk for deleveloping critical illness hyperglycemia.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Children's Healthcare of Atlanta at Egleston - Pediatric Cardiac Intensive Care Unit
Atlanta, Georgia, 30308
Children's Healthcare of Atlanta at Egleston - Pediatric Intensive Care Unit
Atlanta, Georgia, 30308
Medical Center of Central Georgia - Pediatric Intensive Care Unit
Macon, Georgia, 31201
About this study
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.
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).
Read the 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.
- Conditions
- Hypoglycemia Hyperglycemia
- Keywords
- Intensive critical care, glycemic control, hypoglycemia, hyperglycemia , insulin treatment, intensive care outcomes, pediatrics
- Medical subject headings
- Hypoglycemia, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5-2012
Secondary outcomes (1)
Consortium of centers practiced at glycemic control in pediatric intensive care unit.
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.
Measured: 5-2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hypoglycemia HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Children's Healthcare of Atlanta
- Responsible party
- Sponsor
- Investigators
- Mark R Rigby, MD, PhD, Principal investigator, Emory University and Children's Healthcare of Atlanta at EglestonCathering M Preissig, MD (Co-I), Study director, Medical Center of Central GeorgiaKevin O Maher, MD (Co-I), Study director, Emory University and Children's Healthcare of Atlanta at EglestonDaniel C Keeton, BA (Coordinator), Study director, Children's Healthcare of Atlanta at Egleston and Emory UniversityJeryl Huckaby, RRT (Coordinator), Study director, Children's Healthcare of Atlanta at Egleston and Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116674
- Sponsor's protocol ID
- IRB00045186
- Other IDs
- R21DK081847, CIH Registry
- Status last verified
- Aug 2015
- First submitted
- 3 May 2010
- Last updated
- 31 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19705188Preissig 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.
PubMed 19628220Preissig 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.
PubMed 20128893Preissig 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.
PubMed 18838924
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01116674
- Acronym / sponsor ID
- IRB00045186
- Conditions
- Hypoglycemia Hyperglycemia
- Keywords
- Intensive critical care, glycemic control, hypoglycemia, hyperglycemia , insulin treatment, intensive care outcomes, pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Children's Healthcare of Atlanta
- Study start
- May 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 day to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Childern upto 18 or 21 years old admitted to pedaitric intensive care units who are ar risk for deleveloping critical illness hyperglycemia.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identify and manage hyperglycemia in pediatric intensive care unit
Time frame: 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.
1 secondary outcome
Consortium of centers practiced at glycemic control in pediatric intensive care unit.
Time frame: 5-2012
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2015.
- Background: PubMed 19705188Preissig 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.
- Background: PubMed 19628220Preissig 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.
- Background: PubMed 20128893Preissig 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.
- Background: PubMed 18838924Preissig 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark R Rigby, MD, PhD principal investigator
Emory University and Children's Healthcare of Atlanta at Egleston
Cathering M Preissig, MD (Co-I) study director
Medical Center of Central Georgia
Kevin O Maher, MD (Co-I) study director
Emory University and Children's Healthcare of Atlanta at Egleston
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoglycemia Hyperglycemia, run by Indiana University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify and manage hyperglycemia in pediatric intensive care unit (time frame: 5-2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01116674, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2015.