Basal Insulin in the Management of Patients With Diabetic Ketoacidosis (DKA)
Completed · Phase 4
Conditions studied: Diabetic Ketoacidosis
In brief
The study is a multicenter, randomized controlled trial to compare the safety and efficacy of insulin analogs and human insulins both during acute intravenous treatment and during the transition to subcutaneous insulin in patients with diabetic ketoacidosis (DKA).
Key facts
- Study ID
- NCT00590044
- Run by
- Emory University
- People needed
- 74
- Starts
- 2007-12-01
- Expected to finish
- 2008-08-01
- Last updated by the study team
- 2018-09-26
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All patients admitted to Grady Memorial Hospital who meet diagnosis criteria of DKA and who are willing to participate in the study protocol will be considered candidates for inclusion into the study.
- Diagnostic Criteria for DKA: Blood glucose > 250 mg/dL, arterial or venous phenol hydroxylase (pH) < 7.3, serum bicarbonate < 18 milliequivalent/L, and moderate to severe ketonemia (acetoacetate ≥ 1:4 or βeta-hydroxybutyrate > 3 mmol).
You may not qualify if…
- Hemodynamic instability (MAP < 50 or patients requiring pressor)
- Significant identifiable medical or surgical illness, including but not limited to: acute myocardial infarction, congestive heart failure; respiratory failure requiring mechanical ventilation; acute or chronic renal insufficiency (serum creatinine > 3.0 mg/dl); end stage liver failure, and cirrhosis.
- Patients with dementia or persistent altered mental status that would prevent collection of consent form and reliable information.
- Pregnancy
Where it is running
- Grady Memorial Hospital — Atlanta, Georgia, United States
- University of Minnesota School of Medicine — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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