Two Bag System for Diabetic Ketoacidosis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetic Ketoacidosis

Intervention / Treatment
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* Other: Two bag system


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Usual care with a one bag system of IV fluids, as recommended in the American Diabetes Association consensus statement guidelines from 2009. | |
| Experimental: Two bag system<br>A two bag system of IV fluids will be used during insulin infusion administration. | Other: Two bag system<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to anion gap closure in hours | 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). | During hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemic episodes | Symptomatic episodes of hypoglycemia | During hospitalization | 
| Hypoxic events | Desaturations less than 89% requiring supplemental oxygen | During hospitalization | 
| Pulmonary edema | Pulmonary edema seen on either chest X-ray or with the change in the lung exam | During hospitalization | 
| Chest pain with EKG changes | Onset of new chest pain with new EKG changes concerning for ischemia | During hospitalization | 
| Hyponatremia events | Sodium values less than 135 mmol/L (corrected for glucose) | During hospitalization | 
| Hypokalemia events | Potassium values less than 3.3 mmol/L | During hospitalization | 
| ICU length of stay | Total time the patient was admitted in the stepdown unit and/or medical ICU | During hospitalization | 
| Changes in mental status | Worsening in either CAM-ICU score or Glasgow Coma Scale | During hospitalization | 
| Total volume of intravenous fluids administered | Total volume of intravenous fluids administered | During hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intravenous fluids, adults, two bag system