Effectiveness of Subcutaneous Glargine On The Time To Closure of The Anion Gap in Patients Presenting to the Emergency Department With Diabetic Keto-acidosis
Information source: The University of Texas Health Science Center, Houston
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Ketoacidosis
Intervention: Insulin Glargine (Drug); Regular Insulin (Drug)
Phase: N/A
Status: Completed
Sponsored by: The University of Texas Health Science Center, Houston Official(s) and/or principal investigator(s):
Pratik B Doshi, MD, Principal Investigator, Affiliation: The University of Texas Health Science Center, Houston
Summary
To determine if co-administration of subcutaneous (SQ)Insulin glargine in combination with
intravenous (IV) insulin decreases the time to resolution of ketoacidosis and requirement
for ICU admission compared to IV insulin with delayed administration of SQ glargine for the
treatment of DKA.
Clinical Details
Official title: Effectiveness of Subcutaneous Glargine On The Time To Closure of The Anion Gap in Patients Presenting to the Emergency Department With Diabetic Keto-acidosis: A Pilot Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Time to anion gap closure
Secondary outcome: Rate of ICU admissionIntensive care unit Length of Stay Hospital Length of stay Rate of hypoglycemia
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age >18 years
- Blood Glucose >200
- pH < 7. 3
- Bicarbonate < 18
- Ketonemia or Ketonuria
- Anion Gap > or = 16
Exclusion Criteria:
- Age < 18 years
- Pregnant
- ESRD
- Prisoners
- Patients in shock or requiring emergency surgery
- Those unwilling to consent for the trial
- Allergic to Insulin Glargine
Locations and Contacts
Lyndon B Johnson Hospital, Houston, Texas 77026, United States
Memorial Herman Hospital-Texas Medical Center, Houston, Texas 77030, United States
Additional Information
Related publications: Shankar V, Haque A, Churchwell KB, Russell W. Insulin glargine supplementation during early management phase of diabetic ketoacidosis in children. Intensive Care Med. 2007 Jul;33(7):1173-8. Epub 2007 May 17.
Starting date: November 2012
Last updated: December 4, 2013
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