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

Completed · Not applicable

Conditions studied: Critical Illness, Hyperglycemia

In brief

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.

Key facts

Study ID

NCT00487006

Run by

Children's Healthcare of Atlanta

People needed

209

Starts

2006-10-01

Expected to finish

2015-02-01

Last updated by the study team

2015-06-16

Who can join

Age: 2 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• - 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.

You may not qualify if…

• - 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.

Where it is running

• Children's Healthcare of Atlanta — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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