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Pilot Study to Evaluate a Method of Controlling High Blood Sugar in the Pediatric Intensive Care Unit
Not Recruiting
Trial ID: NCT00240149
Purpose
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.
Official Title
Pilot Study Evaluating Use of Insulin-Glucose Algorithm and Glucose Monitoring Techniques to Control Hyperglycemia in the Pediatric Intensive Care Unit
Stanford Investigator(s)
Bruce Buckingham
Professor of Pediatrics (Endocrinology) at the Lucile Salter Packard Children's Hospital, Emeritus
Eligibility
Inclusion Criteria::
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
repeat participation
Intervention(s):
drug: Regular Insulin via Insulin-Glucose Algorithm
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305