Subcutaneous Aspart Insulin to Treat Diabetic Ketoacidosis (DKA) and Beta-Hydroxybutyrate Testing in DKA
Information source: Rush University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Ketoacidosis
Intervention: Insulin (Aspart Insulin [Novolog], Regular Insulin) (Drug)
Phase: N/A
Status: Completed
Sponsored by: Rush University Medical Center Official(s) and/or principal investigator(s): Rema A Gupta, MD, Principal Investigator, Affiliation: Rush University Medical Center David Baldwin, MD, Principal Investigator, Affiliation: Rush University Medical Center
Summary
The purpose of this study is to determine whether insulin administered by a subcutaneous
injection is effective in the treatment of a diabetic crisis and to determine if
beta-hydroxybutyrate is useful to monitor during treatment of a diabetic crisis.
Clinical Details
Official title: Subcutaneous Aspart Insulin and Point of Care Beta Hydroxybutyrate Testing: A New Paradigm for the Management of Diabetic Ketoacidosis
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Hours to resolution of ketoacidosis as defined as beta-hydroxybutyrate <0.6Hours to achieve blood glucose less than 200mg/dl
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria: age 18 or older
- venous pH < 7. 3 or arterial < 7. 35
- at least 2 of the following 3:
1. serum HCO3 < 18/anion gap > 16
2. serum glucose > 300 mg/dl
3. serum acetone positive
Exclusion Criteria:
- pregnant
- less than age 18
Locations and Contacts
Rush University Medical Center, Chicago, Illinois 60612, United States
Additional Information
Starting date: January 2005
Last updated: August 14, 2012
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