Study of High Blood Sugars and Insulin in Hospitalized, Critically Ill Children (CIH)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00487006
First received: June 13, 2007
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

BACKGROUND AND PURPOSE

Critical illness hyperglycemia (CIH) - elevated blood glucose in the critically ill patient population - has gained much interest among health care providers over the past several years. Clinical studies in adults have documented a high rate of hyperglycemia in some post-surgical and medical intensive care units (ICUs). However, the primary reasons for interest in this topic are not due just to its high rate, but also to the fact that by returning the high glucose levels found in this population to normal with insulin therapy can dramatically improve clinical outcomes by decreasing both morbidity and long-term mortality. Because of this, aggressive glucose control has become common practice in adult ICU critical care management.

Although there is substantial data describing the high incidence of CIH in adult patients, there is little information regarding this condition in children. A single retrospective study recently published also suggested a high incidence of CIH in children with critical illness secondary to both medical and surgical causes. It is yet to be determined if, like in adults, normalizing blood glucose levels with insulin improves outcomes in this pediatric population. Because evidence appears compelling that hyperglycemia is both common and detrimental in adults, many pediatric ICUs have likewise begun to focus on aggressively treating hyperglycemia in critically ill children.

The proposed study is a prospective observational pilot study to occur in the Pediatric Intensive Care Unit (PICU) at Children's Healthcare of Atlanta at Egleston. This prospective pilot study is being done to evaluate the endocrine factors associated with, if not responsible for, CIH, and the changes that take place with the restoration of normal blood glucose levels by insulin therapy.

To address these profound issues this study will pursue two interrelated Aims:

Aim #1: To determine if critical illness hyperglycemia is associated with absolute insulin deficiency, peripheral insulin resistance, or both.

Aim #2: To characterize the requirement of insulin required to initially restore and maintain normal blood glucose levels, and compare the changes in insulin that take place with this normalization in patients with CIH.

We hypothesize that the hyperglycemic response to critical illness will be associated with abnormally low levels of insulin as compared to patients without critical illness hyperglycemia.


Condition Intervention
Critical Illness
Hyperglycemia
Other: Serum Lab testing

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Insulin Resistance Versus Absolute Insulin Deficiency: Evaluating the Mechanism of Hyperglycemia in Pediatric Critical Illness

Resource links provided by NLM:


Further study details as provided by Children's Healthcare of Atlanta:

Primary Outcome Measures:
  • We hypothesize that the hyperglycemic response to critical illness will be associated with abnormally low levels of endogenous insulin as compared to patients without critical illness hyperglycemia. [ Time Frame: At time of consent, 24 hours, 72 hours, and if applicable every additional 72 hours until insulin discontinued. A final lab 24 hours after D/C of insulin will be performed. ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2006
Estimated Study Completion Date: April 2015
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: At risk for CIH/with CIH
In hyperglycemic patients who will be starting insulin infusions to control hyperglycemia, blood will be drawn just prior to initiation of insulin infusion for the following levels: insulin, glucose, and C-peptide. These levels will be re-drawn upon achieving euglycemia, at 24 hours following that, then every three days. Levels will be again drawn once the insulin infusion is stopped/when CIH has resolved, and 24 hours following discontinuation of insulin infusion. At each timepoint the patient's clinical status will be documented and significant interval changes (intubation/extubation, change in pressor need), amount of dextrose (mg/kg/hour) supplied, and other concurrent medicines and doses will be recorded.
Other: Serum Lab testing
Serum Lab testing
Active Comparator: At risk for CIH/without CIH
For comparative controls, insulin, C-peptide, and glucose levels will be drawn from ICU patients aged 2-12 years at similar "risk" (mechanical ventilation or vasoactive medications) but without CIH. The above labs will be drawn and data gathered near the time of risk, 24 hours later, then in 3 days following, for a total of three timepoints.
Other: Serum Lab testing
Serum Lab testing
Active Comparator: Not at risk for CIH/without CIH
In addition, other ICU patients aged 2-12 years that are deemed NOT at risk for critical illness hyperglycemia will also be evaluated to serve as a group not "at risk" but admitted to the PICU as a further control population. Like Group B, the above labs will be drawn and data gathered at the time consent is obtained, 24 hours later, then in 3 days following, for a total of three timepoints
Other: Serum Lab testing
Serum Lab testing

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • - All patients between ages 2 and 12 years of age admitted to the pediatric ICU who meet criteria for critical illness hyperglycemia (ie: all patients on mechanical ventilation, all patients on vasoactive medications, patients deemed otherwise "at risk" for CIH by attending service) and are started on our standard CIH screening and treatment protocol will comprise the pool of potential study candidates.

Exclusion Criteria:

  • - Certain patients who meet criteria for critical illness hyperglycemia and thus are started on insulin will be excluded from this study: Age Patients less than 2 or greater than 12 years of age will be excluded from this study to decrease age variability.

Pre-existing known endocrine disorder Patients with known or suspected Type 1 diabetes will be excluded because of their pre-existing absolute lack of insulin production secondary to autoimmune β cell destruction.

Oncology patients Oncology patients will be excluded because of the effects of immunosuppressants on study markers.

Renal replacement therapy Patients on continuous veno-venous hemofiltration (CVVH) or any type of dialysis (intermittent dialysis, peritoneal dialysis) will be excluded as it is unclear how different forms of renal replacement therapy affect insulin levels, and certain types of dialysis affect glucose and insulin levels (i.e. dextrose containing PD fluid).

Non-adherence Inability or unwillingness of the legal guardian to provide consent, or unwillingness of the child to provide assent.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487006

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Mark Rigby, MD Children's Healthcare of Atlanta/Emory University
  More Information

No publications provided

Responsible Party: Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT00487006     History of Changes
Other Study ID Numbers: CIH
Study First Received: June 13, 2007
Last Updated: May 1, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Critical Illness
Hyperglycemia
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014