Two Bag System for Diabetic Ketoacidosis
- Conditions
- Diabetic Ketoacidosis
- Interventions
- Other: Two bag system
- Registration Number
- NCT03660189
- Lead Sponsor
- MetroHealth Medical Center
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 57
-
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
- Pregnancy
- Hyperglycemic hyperosmolar state
- Ketosis from other etiology such as starvation or alcoholic ketosis
- Acute exacerbation of congestive heart failure
- Acute coronary syndrome or non-ST elevation MI
- Pulmonary edema from other cause such as decompensated liver failure or acute renal failure
- Renal failure requiring renal replacement therapy (hemodialysis)
- Septic shock
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Two bag system Two bag system A two bag system of IV fluids will be used during insulin infusion administration.
- Primary Outcome Measures
Name Time Method Time to Anion Gap Closure in Hours while in DKA Anion gap (Na - Cl - HCO3) is within normal range when corrected for the albumin (time to anion gap closure will be defined as the time to the first occurrence of a normal anion gap).
- Secondary Outcome Measures
Name Time Method Total Volume of Intravenous Fluids Administered while in DKA Total volume of intravenous fluids administered
Hypernatremia while in DKA Maximum sodium level \> 153 mmol/L
Hyperkalemia while in DKA Maximum K level \> 5.3 mmol/L
Changes in Mental Status while in DKA Worsening in either CAM-ICU score or Glasgow Coma Scale
Pulmonary Edema while in DKA Pulmonary edema seen on either chest X-ray or with the change in the lung exam
Hyponatremia Events while in DKA Sodium values less than 135 mmol/L (corrected for glucose)
Hypokalemia Events while in DKA Potassium values less than 3.3 mmol/L
ICU Length of Stay during hospitalization Total time the patient was admitted in the stepdown unit and/or medical ICU
Number of Participants Experiencing Hypoglycemic Episodes while in DKA Symptomatic episodes of hypoglycemia
Number of Participants Experiencing Hypoxic Episodes while in DKA Desaturations less than 89% requiring supplemental oxygen
Chest Pain With EKG Changes while in DKA Onset of new chest pain with new EKG changes concerning for ischemia
Trial Locations
- Locations (1)
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States