Status:
COMPLETED
Pilot Study to Evaluate a Method of Controlling High Blood Sugar in the Pediatric Intensive Care Unit
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Medtronic
Conditions:
Hyperglycemia
Eligibility:
All Genders
1-18 years
Phase:
NA
Brief 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...
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 manageme...
Eligibility Criteria
Inclusion
- :
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00240149
Start Date
October 1 2005
End Date
March 1 2006
Last Update
December 20 2007
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Lucile Packard Childrens Hospital - PICU
Stanford, California, United States, 94305
2
Stanford University School of Medicine
Stanford, California, United States, 94305