Two Bag System for Diabetic Ketoacidosis
Sponsored by MetroHealth Medical Center
About this trial
Last updated 8 months ago
Study ID
IRB18-00025
Status
Terminated
Type
Interventional
Phase
N/A
Placebo
No
Accepting
18 to 85 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 2 years ago
What is this trial about?
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.
What are the participation requirements?
Inclusion Criteria
1. Diagnosis of diabetic ketoacidosis defined as:
1. Blood sugar greater than 250 mg/dl
2. Venous pH less than 7.25
3. Bicarbonate less than 18
4. Evidence of ketone formation with either positive urine ketones or elevated beta-hydroxybutyrate > 3
5. Anion gap greater than 10 +/ - 2 (or higher than expected anion gap corrected for albumin)
2. 18-85 years of age
Exclusion Criteria
1. Pregnancy
2. Hyperglycemic hyperosmolar state
3. Ketosis from other etiology such as starvation or alcoholic ketosis
4. Acute exacerbation of congestive heart failure
5. Acute coronary syndrome or non-ST elevation MI
6. Pulmonary edema from other cause such as decompensated liver failure or acute renal failure
7. Renal failure requiring renal replacement therapy (hemodialysis)
8. Septic shock