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Pilot Study to Evaluate a Method of Controlling High Blood Sugar in the Pediatric Intensive Care Unit
Trial ID: NCT00240149
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.
Pilot Study Evaluating Use of Insulin-Glucose Algorithm and Glucose Monitoring Techniques to Control Hyperglycemia in the Pediatric Intensive Care Unit
Patients between 1-18 years of age admitted to the PICU at LPCH will be asked to
participate in a randomized feasibility trial during their hospitalization. This initial
age restriction will be adjusted as experience is gained.
Patient displays evidence of hyperglycemia (>150mg/dl) Exclusion Criteria:Initially,
patients younger than 5 years of age will be excluded. These patients appear to have a
higher sensitivity to insulin as well as a proposed higher risk of hypoglycemia. Since this
is a feasibility trial using insulin to control glucose, we feel that it would be prudent
to establish success in an older patient population before extending the study to include
younger children and infants. In addition, our PICU study revealed no significant increased
risk of hyperglycemia based on age. This age restriction will be adjusted after the
mid-study data analysis.
Patients who are known to be pregnant will be excluded.
Patients who have known platelet dysfunction will be excluded.
Patients without intact, uninfected skin at the future site of sensor insertion.
Study patients re-admitted to the PICU after hospital discharge will not be eligible for
drug: Regular Insulin via Insulin-Glucose Algorithm
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