NCT03660189

Two Bag System for Diabetic Ketoacidosis

The "Two Bag" System for Treatment of Adults With Diabetic Ketoacidosis: a Prospective Randomized Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: MetroHealth Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Diabetic Ketoacidosis

Interventions

Type	Name	Description
OTHER	Two bag system	The two IV fluid bags have identical fluids and electrolytes, except one has 10% dextrose and the other has no dextrose. The two fluid bags run simultaneously and their rates are adjusted according to the patient's blood sugar.

Timeline

• Start date: 2018-09-17
• Primary completion: 2023-06-15
• Completion: 2023-06-15
• First posted: 2018-09-06
• Last updated: 2024-10-31
• Results posted: 2024-10-31

Locations

1 site across 1 country: United States