Pediatric Patient (1m-21y)Phase 3PedETrolNCT01116752
Pediatric Intensive Care Units (ICUs) at Emory-Children's Center Glycemic Control: The PedETrol Trial
A Phase 3 study of Pediatric Patient (1m-21y) and ICU Admission, run by Indiana University at 1 site in United States.
Trial summary
The primary goal of this project is to determine whether normalizing hyperglycemia is a safe approach to improve multisystem organ function in critically ill children requiring intensive care. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Pediatric Patient (1m-21y), ICU Admission, Hyperglycemia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Aug 2015
- Phase
- Phase 3
- 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 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Critically ill children with hyperglycemia, defined as persistent BG >140 mg/dL, meeting the following criteria will be targeted for this study.
- Age 1 month -18 years old
- Admission to the pediatric medical/surgical or pediatric cardiac intensive care unit
- Require mechanical ventilation and/or vasopressors/inotropic infusions
- Patient or family member available to discuss informed consent criteria and provide informed consent.
Who cannot join
- Age >18 years old
- Age <1 month of chronologic age
- Patients with type I diabetes mellitus or other conditions in which there is impaired glycogen stores or counter regulatory response (i.e. inborn error of metabolism, fulminant hepatic failure)
- Patients with "do not resuscitate", "do not intubate", or "do not escalate care" orders
- Lack of availability by parent or legal guardian to assist in the consent process will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322
About this study
Official title: Pediatric ICUs at Emory-Children's Center Glycemic Control: The PedETrol Trial
The primary goal of this project is to determine whether normalizing hyperglycemia is a safe approach to improve multisystem organ function in critically ill children requiring intensive care. The will are conducting the "PedETrol" (the "Pediatric ICUs at Emory-Children's Center Glycemic Control: The PedETrol Trial) Trial, a 4-year single-center, prospective, randomized clinical trial to evaluate the outcome benefit, safety and resource utilization impact of maintaining strict glucose control in children with life-threatening conditions.
***This study is supported by an Research Project Grant (RO1 grant) (MRR) via the National Heart, Lung, and Blood Institute (NHLBI).
Read the detailed description
Many reports demonstrate improved outcomes in critically ill adults who develop hyperglycemia by rigorous glycemic. Medical oversight committees (including the Institutes of Healthcare Improvement, the American Diabetes Association, and Society of Critical Care Medicine, among others) recommend routine glycemic control during critical illness. Some studies show high rates of hypoglycemia and have highlighted the concern of this approach to care. Little data exists on how hyperglycemia and glycemic control affects critically ill children. Our practice group has developed a regular approach to glycemic control that appears effective and safe and controlling hyperglycemia and the investigators believe that due to our unique experience and expertise in this field, the investigators are well-poised to conduct further much needed studies regarding glycemic control in children. To specifically address the void of knowledge regarding glycemic control in critically ill children, the investigators will conduct a single-center randomized controlled trial to ascertain whether there is vital organ system, outcome, and resource utilization benefit to strict glycemic control vs. more conservative control in children requiring intensive care. The "PedETrol" (the "Pediatric ICUs at Emory-Children's Center Glycemic Control) Trial will study 1,004 children admitted to the ICU for medical, surgical, or cardiac conditions requiring mechanical ventilation and/or vasopressor/i support who develop hyperglycemia, defined as persistent blood glucose >140 mg/dL). Participants will be randomized to either receive strict glycemic control (80-140 mg/dL) or more conservative control (190-220 mg/dL). Insulin infusions will be used to maintain blood glucose in these ranges. In addition to assessing organ and outcome specific efficacy parameters, the investigators will meticulously evaluate for untoward effects including hypoglycemia, and determine the impact of this practice on costly medical resources. All children <1 year old and 25% of those >1 year old, will be able to receive continuous glucose monitoring via interstitial glucometry. This appears to be the first glycemic control trial in any critical care population to make use of continuous glucose monitoring.
- Conditions
- Pediatric Patient (1m-21y), ICU Admission, Hyperglycemia
- Being tested
- Active Glycemic Control Strict (80-140mg/dL) vs. Conservative (190-220mg/dL) (with or without Continuous Glucose Monitoring)
- Keywords
- Intensive Care, Critical care, Glycemic Control, Hypoglycemia, Hyperglycemia, Insulin treatment, Organ Function, PELOD, Outcomes, Pediatrics
- Medical subject headings
- Hyperglycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Glycemic Control Strict (80-140mg/dL) vs. Conservative (190-220mg/dL) (with or without Continuous Glucose Monitoring)Other
In addition to glycemic control in 2 groups, all children <1 year old and 25% of those >1 year old, will be able to receive continuous glucose monitoring via interstitial glucometry.
| Study group | Role | What they receive |
|---|---|---|
| Strict control | Active comparator | Children requiring intensive care and mechanical ventilation and/or vasopressor/inotropic support who develop critical illness hyperglycemia (persistent BG values if >140 mg/dL) will be randomized to have their glucose levels managed with insulin infusions and receive strict glycemic control (80-140 mg/dL) Receives: Other: Active Glycemic Control Strict (80-140mg/dL) vs. Conservative (190-220mg/dL) (with or without Continuous Glucose Monitoring) |
| Conservative control | Active comparator | Children requiring intensive care and mechanical ventilation and/or vasopressor/inotropic support who develop critical illness hyperglycemia (persistent BG values if >140 mg/dL) will be randomized to have their glucose levels managed with insulin infusions and receive conservative control (190-220 mg/dL). Receives: Other: Active Glycemic Control Strict (80-140mg/dL) vs. Conservative (190-220mg/dL) (with or without Continuous Glucose Monitoring) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine recovery of organ function in critically ill children subject to either strict or conservative glycemic control.
Determine the rapidity of recovery of organ function in critically ill children subject to either strict or conservative glycemic control by assessing organ function using Pediatric Logistic Organ Dysfunction (PELOD) scoring 6 days following development of hyperglycemia.
Measured: 8/1/2010-3/31/2014
Secondary outcomes (2)
Adverse effect rates
Impact on mortality and other morbidity measures (i.e. ICU length of stay [LOS], mechanical ventilation days, inotrope scores, hospital acquired infections0 1) Adverse effect rates (including moderate (blood glucose [BG] <60 mg/dL) and severe (BG <40 mg/dL) hypoglycemia) associated with strict versus conservative glycemic control in pediatric critical illness.
Measured: 8/1/2010-3/31/2014
Glycemic control compared to conservative control on care cost
Determine the effect of strict glycemic control compared to conservative control on care cost (i.e. hospital and ICU costs) and medical resource utilization (i.e. ICU and mechanical ventilation days) in critically ill children.
Measured: 8/1/2010-3/31/2014
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 startAug 2010
- Primary completionDec 2013
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pediatric Patient (1m-21y)Studies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), 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 Egleston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116752
- Sponsor's protocol ID
- IRB00005792
- Other IDs
- RO1, Pedetrol5792
- Acronym
- PedETrol
- 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 20128893Vlasselaers D, Milants I, Desmet L, Wouters PJ, Vanhorebeek I, van den Heuvel I, Mesotten D, Casaer MP, Meyfroidt G, Ingels C, Muller J, Van Cromphaut S, Schetz M, Van den Berghe G. Intensive insulin therapy for patients in paediatric intensive care: a prospective, randomised controlled study. Lancet. 2009 Feb 14;373(9663):547-56. doi: 10.1016/S0140-6736(09)60044-1. Epub 2009 Jan 26.
PubMed 19176240Preissig 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 ICUs at Emory-Children's Center Glycemic Control: The PedETrol Trial
- ClinicalTrials.gov ID
- NCT01116752
- Acronym / sponsor ID
- PedETrol / IRB00005792
- Conditions
- Pediatric Patient (1m-21y), ICU Admission, Hyperglycemia
- Keywords
- Intensive Care, Critical care, Glycemic Control, Hypoglycemia, Hyperglycemia, Insulin treatment, Organ Function, PELOD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Children's Healthcare of Atlanta
- Study start
- Aug 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Aug 2015 (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 primary goal of this project is to determine whether normalizing hyperglycemia is a safe approach to improve multisystem organ function in critically ill children requiring intensive care. The will are conducting the "PedETrol" (the "Pediatric ICUs at Emory-Children's Center Glycemic Control: The PedETrol Trial) Trial, a 4-year single-center, prospective, randomized clinical trial to evaluate the outcome benefit, safety and resource utilization impact of maintaining strict glucose control in children with life-threatening conditions.
***This study is supported by an Research Project Grant (RO1 grant) (MRR) via the National Heart, Lung, and Blood Institute (NHLBI).
Detailed description
Many reports demonstrate improved outcomes in critically ill adults who develop hyperglycemia by rigorous glycemic. Medical oversight committees (including the Institutes of Healthcare Improvement, the American Diabetes Association, and Society of Critical Care Medicine, among others) recommend routine glycemic control during critical illness. Some studies show high rates of hypoglycemia and have highlighted the concern of this approach to care. Little data exists on how hyperglycemia and glycemic control affects critically ill children. Our practice group has developed a regular approach to glycemic control that appears effective and safe and controlling hyperglycemia and the investigators believe that due to our unique experience and expertise in this field, the investigators are well-poised to conduct further much needed studies regarding glycemic control in children. To specifically address the void of knowledge regarding glycemic control in critically ill children, the investigators will conduct a single-center randomized controlled trial to ascertain whether there is vital organ system, outcome, and resource utilization benefit to strict glycemic control vs. more conservative control in children requiring intensive care. The "PedETrol" (the "Pediatric ICUs at Emory-Children's Center Glycemic Control) Trial will study 1,004 children admitted to the ICU for medical, surgical, or cardiac conditions requiring mechanical ventilation and/or vasopressor/i support who develop hyperglycemia, defined as persistent blood glucose >140 mg/dL). Participants will be randomized to either receive strict glycemic control (80-140 mg/dL) or more conservative control (190-220 mg/dL). Insulin infusions will be used to maintain blood glucose in these ranges. In addition to assessing organ and outcome specific efficacy parameters, the investigators will meticulously evaluate for untoward effects including hypoglycemia, and determine the impact of this practice on costly medical resources. All children <1 year old and 25% of those >1 year old, will be able to receive continuous glucose monitoring via interstitial glucometry. This appears to be the first glycemic control trial in any critical care population to make use of continuous glucose monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strict control | Active comparator | Other: Active Glycemic Control Strict (80-140mg/dL) vs. Conservative (190-220mg/dL) (with or without Continuous Glucose Monitoring)Children requiring intensive care and mechanical ventilation and/or vasopressor/inotropic support who develop critical illness hyperglycemia (persistent BG values if >140 mg/dL) will be randomized to have their glucose levels managed with insulin infusions and receive strict glycemic control (80-140 mg/dL) |
| Conservative control | Active comparator | Other: Active Glycemic Control Strict (80-140mg/dL) vs. Conservative (190-220mg/dL) (with or without Continuous Glucose Monitoring)Children requiring intensive care and mechanical ventilation and/or vasopressor/inotropic support who develop critical illness hyperglycemia (persistent BG values if >140 mg/dL) will be randomized to have their glucose levels managed with insulin infusions and receive conservative control (190-220 mg/dL). |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Critically ill children with hyperglycemia, defined as persistent BG >140 mg/dL, meeting the following criteria will be targeted for this study.
- Age 1 month -18 years old
- Admission to the pediatric medical/surgical or pediatric cardiac intensive care unit
- Require mechanical ventilation and/or vasopressors/inotropic infusions
- Patient or family member available to discuss informed consent criteria and provide informed consent.
Key exclusion criteria (5 listed)
- Age >18 years old
- Age <1 month of chronologic age
- Patients with type I diabetes mellitus or other conditions in which there is impaired glycogen stores or counter regulatory response (i.e. inborn error of metabolism, fulminant hepatic failure)
- Patients with "do not resuscitate", "do not intubate", or "do not escalate care" orders
- Lack of availability by parent or legal guardian to assist in the consent process will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Glycemic Control Strict (80-140mg/dL) vs. Conservative (190-220mg/dL) (with or without Continuous Glucose Monitoring)In addition to glycemic control in 2 groups, all children <1 year old and 25% of those >1 year old, will be able to receive continuous glucose monitoring via interstitial glucometry. | Other | Conservative control, Strict control |
Primary outcome
Determine recovery of organ function in critically ill children subject to either strict or conservative glycemic control.
Time frame: 8/1/2010-3/31/2014
Determine the rapidity of recovery of organ function in critically ill children subject to either strict or conservative glycemic control by assessing organ function using Pediatric Logistic Organ Dysfunction (PELOD) scoring 6 days following development of hyperglycemia.
2 secondary outcomes
Adverse effect rates
Time frame: 8/1/2010-3/31/2014
Glycemic control compared to conservative control on care cost
Time frame: 8/1/2010-3/31/2014
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 19176240Vlasselaers D, Milants I, Desmet L, Wouters PJ, Vanhorebeek I, van den Heuvel I, Mesotten D, Casaer MP, Meyfroidt G, Ingels C, Muller J, Van Cromphaut S, Schetz M, Van den Berghe G. Intensive insulin therapy for patients in paediatric intensive care: a prospective, randomised controlled study. Lancet. 2009 Feb 14;373(9663):547-56. doi: 10.1016/S0140-6736(09)60044-1. Epub 2009 Jan 26.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Pediatric Patient (1m-21y) and ICU Admission, run by Indiana University at 1 site 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 5 inclusion and 5 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 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Determine recovery of organ function in critically ill children subject to either strict or conservative glycemic control. (time frame: 8/1/2010-3/31/2014). 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 NCT01116752, which also lists 5 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.