Pilot Study to Evaluate a Method of Controlling High Blood Sugar in the Pediatric Intensive Care Unit
Condition: Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      Recent studies of adult intensive care unit (ICU) patients have shown significantly decreased
      morbidity and mortality when blood sugar concentrations are closely controlled. The safety
      and efficacy of this type of blood sugar management has not been studied in the pediatric ICU
      population. Based on the current pediatric literature data as well as our extensive
      retrospective study, blood sugar concentrations have a potentially profound role to play
      among PICU patients. In preparation for a multi-center randomized control trial, we propose a
      prospective feasibility study to evaluate the safety and effectiveness of using an insulin
      delivery algorithm to manage blood sugar in the PICU. Our hypothesis for this feasibility
      trial is that uniformly monitoring and controlling blood glucose with a
      Discrete-Closed-Loop(DCL) insulin delivery algorithm will be an effective, safe, and
      consistent means of delivering insulin to manage glucose in the pediatric intensive care
      unit.
    

Detailed description: 
      The Diabetes Control and Complications Trial (DCCT) demonstrated that long-term microvascular
      complications from hyperglycemia could be reduced in adolescents and adults by intensive
      diabetes management.1 Hyperglycemia has also been shown to be an acute risk factor for poor
      outcome in a variety of adult cases including trauma, cardiac,2 surgical, stroke, and head
      injury patients.

      Moreover, control of hyperglycemia improves the outcome of these critically ill adult
      patients in intensive care unit (ICU) settings. In a prospective randomized study, Van den
      Berghe et al. reported on 1,548 patients admitted to an adult surgical ICU. During admission,
      intensive treatment with intravenous insulin to control hyperglycemia in both diabetics and
      non-diabetics reduced the risk of death by 42%, overall in-hospital mortality by 34%, sepsis
      by 46%, and acute renal failure by 41%.3 Utilizing less stringent criteria for glycemic
      control, Finney et al. also reported similar findings.4

      While these studies have emphasized the value of controlling hyperglycemia in the adult ICU,
      there have been relatively few studies evaluating the incidence of hyperglycemia, and its
      correlates, in the PICU, and no interventional studies. 5,6

      Because of the limited pediatric data available and the impressive findings displayed in the
      adult literature, we performed a retrospective chart review of all pediatric patients
      admitted to our PICU over a 13 month period. The goals of this study were to gain a better
      understanding of current glucose monitoring techniques in the PICU as well how hyperglycemia
      correlates with morbidity and mortality in pediatrics.

      The results confirmed our hypothesis that a higher peak glucose during an admission is
      associated with longer LOS and a higher mortality rate. 7

      As demonstrated in adults, control of hyperglycemia has the potential to have a profound
      impact on the morbidity and mortality of patients in the PICU. Our preliminary study clearly
      showed that hyperglycemia is associated with increased LOS and mortality. Unfortunately, the
      true clinical impact of controlling hyperglycemia on pediatric ICU patients is not known. By
      more accurately and more safely controlling hyperglycemia in the PICU, we have the
      opportunity to improve on the standard of care as well as to potentially improve the overall
      clinical outcome of PICU patients. Once the use of an insulin delivery algorithm and our
      methods for glucose monitoring have been explored in this randomized controlled feasibility
      study, this form of improved glucose management can be formally tested in a large
      multi-center trial in the PICU setting.
    

Intervention name(s): Regular Insulin via Insulin-Glucose Algorithm
Intervention type(s): Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment