Two Bag System for Diabetic Ketoacidosis (NCT03660189) | Clinical Trial Compass
TerminatedNot Applicable
Two Bag System for Diabetic Ketoacidosis
Stopped: COVID19 restrictions impeded our ability to recruit patients further
United States57 participantsStarted 2018-09-17
Plain-language summary
This is a study investigating the best way to treat diabetic ketoacidosis (DKA) with intravenous (IV) fluids in the hospital. The purpose of this study is to determine whether the "two bag" system of administering IV fluids for the treatment of adults with DKA leads to a shorter time requiring intravenous insulin (a shorter time to anion gap closure), when compared to usual care the traditional "one bag" system of IV fluids. Participants will be assigned randomly to either the usual care group or the "two bag" system group. Based on studies performed in the past, the investigators predict that patients treated with the two bag system of IV fluids for DKA will have a significantly shorter time requiring treatment with intravenous insulin when compared to the traditional one bag system.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Diagnosis of diabetic ketoacidosis defined as:
✓. Blood sugar greater than 250 mg/dl
✓. Venous pH less than 7.25
✓. Bicarbonate less than 18
✓. Evidence of ketone formation with either positive urine ketones or elevated beta-hydroxybutyrate \> 3
✓. Anion gap greater than 10 +/ - 2 (or higher than expected anion gap corrected for albumin)
✓. 18-85 years of age
Exclusion criteria
✕. Pregnancy
✕. Hyperglycemic hyperosmolar state
✕. Ketosis from other etiology such as starvation or alcoholic ketosis
✕. Acute exacerbation of congestive heart failure