Two Bag System for Diabetic Ketoacidosis

The two bag system has been studied in the pediatric population and is used frequently in
pediatric intensive care units. It involves two bags of identical fluids with electrolytes,
except one bag has 0% dextrose and the other has 10% dextrose. The two fluid bags run
simultaneously into a single IV. The rates of the two fluid bags are adjusted according to
the patient's blood sugar. Since the hyperglycemia in DKA typically corrects before the
ketosis, this provides a more efficient method of titrating the dextrose concentration based
on the patient's needs, while continuing to infuse the insulin at a constant rate to prevent
further ketogenesis. The benefits of the two bag system from the pediatric literature
include: decreased response time to IV fluid changes, decreased time to correction of
bicarbonate and ketones, and decreased total IV fluid volume administered. There was one
retrospective study of the two bag system in adults, which showed decreased time to anion gap
closure and decreased hypoglycemic events. To this date, there are no prospective randomized
trials to evaluate the efficacy of the two bag system in adults.

Patients admitted with DKA in the critical care pavilion will be randomized to either the
"two bag system" or "usual care" group.

Patients in both groups will be treated for DKA with IV fluid resuscitation for dehydration
and an insulin infusion according to usual care, recommended at 0.1 U/kg/hr.

The two bag system of IV fluids will be ordered as delineated below:

If blood sugar is > 300, run D10 solution at 0 ml/hr and saline solution at 200 ml/hr.

If blood sugar is 250-299, run D10 solution at 50 ml/hr and saline solution at 150 ml/hr.

If blood sugar is 200-249, run D10 solution at 100 ml/hr and saline solution at 100 ml/hr.

If blood sugar is 150-199, run D10 solution at 150 ml/hr and saline solution at 50 ml/hr.

If blood sugar is < 150, run D10 solution at 200 ml/hr and saline solution at 0 ml/hr.

The control group will be usual care of DKA based on the American Diabetes Association
Guidelines using a "one bag system."

In both groups, blood sugars will be checked every hour while on the insulin drip. A basic
metabolic panel will be checked every 4 hours to monitor the anion gap. Once the anion gap is
closed on two occasions and the subject is able to tolerate an enteral diet, the patient will
be transitioned to subcutaneous insulin and insulin drip will be discontinued.

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