Study Results
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View full resultsBasic Information
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COMPLETED
NA
75 participants
INTERVENTIONAL
2004-08-31
2012-09-30
Brief Summary
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The investigators hypothesize that the addition of insulin glargine during the early phase of management of DKA will accelerate acidosis correction, decrease the length of insulin infusion, and decrease the total intensive care unit time in children admitted to the ICU.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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Glargine
0.3u/kg of glargine, subcutaneously, once
glargine
0.3u/kg of glargine, subcutaneously, once
Placebo
0.3u/kg of saline, subcutaneously, once
saline
0.3u/kg of saline, subcutaneously, once
Interventions
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glargine
0.3u/kg of glargine, subcutaneously, once
saline
0.3u/kg of saline, subcutaneously, once
Eligibility Criteria
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Inclusion Criteria
* Established history of insulin dependent diabetes
AND:
* Chief c/o hyperglycemia or vomiting
* Venous pH \< 7.24
* Serum Bicarbonate \< 18
* Blood glucose \> 150
* Urinary Ketones
Exclusion Criteria
* New onset diabetes
* Received IV insulin bolus prior to arrival to VCH Emergency Room (ER)
* Venous pH \> 7.24
* Serum Bicarbonate \> 18
* Pregnancy
* Received glargine within 12 hours prior to arrival to VCH Emergency Room/Pediatric Critical Care Unit
6 Years
18 Years
ALL
No
Sponsors
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Vanderbilt University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Sheila McMorrow, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University
Locations
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Vanderbilt University Monroe Carell Children's Hospital
Nashville, Tennessee, United States
Countries
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Other Identifiers
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040643
Identifier Type: -
Identifier Source: org_study_id
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