THE "TWO BAG" SYSTEM FOR TREATMENT OF ADULTS WITH DIABETIC KETOACIDOSIS: A PROSPECTIVE RANDOMIZED TRIAL

Abstract

SESSION TITLE: Tuesday Abstract Posters SESSION TYPE: Original Investigation Posters PRESENTED ON: 10/22/2019 01:00 PM - 02:00 PM PURPOSE: The “two bag” system (2BAG) for intravenous (IV) fluid administration is efficacious in treating diabetic ketoacidosis (DKA) among children. It involves two bags of saline: one with 10% dextrose and the other without dextrose. The two fluid bags are administered simultaneously at a total constant rate, and rates of individual fluid bags are adjusted by a nurse-driven protocol per patients’ glucose levels. To our knowledge, there have been no prospective trials studying 2BAG in adults with DKA. The aim of this prospective randomized controlled trial is to determine whether 2BAG closes the anion gap faster than usual care using a one bag system recommended by the American Diabetes Association (ADA). METHODS: Adult patients admitted with DKA to the medical stepdown or intensive care units at an academic, urban, safety net hospital were randomized to either 2BAG (intervention) or the usual care (control) group. Exclusion criteria included pregnancy, septic shock, heart failure, and renal failure requiring dialysis. Subjects in both groups initially received insulin infusions at 0.1 units/kg/hour. The control group was treated with IV fluids according to ADA guidelines for DKA management. The primary endpoint was time from initial laboratory studies confirming DKA to anion gap closure. This study was approved by the Human Subjects Division of the MetroHealth System (IRB #18-00025). RESULTS: Twenty-one subjects were recruited over the first 6 months (11 were randomized to the 2BAG arm). Mean age was 38.0 ± 14.4 years and 12 (57%) were female. Fourteen (67%) of subjects had Type 1 diabetes mellitus (DM). The mean pH at admission was 7.16 ± 0.12, with no significant difference between the two groups. In the preliminary analysis, there was no difference in time to anion gap closure between the control and 2BAG groups (median: 11.9 (interquartile range (IQR): 4.5-17.1) vs. median: 13.2 (IQR: 9.6-14.6) hours, Wilcoxon rank-sum test p=0.89). The IQR was significantly wider in the control group, as compared to the 2BAG group. No significant adverse events were noted among any subjects. CONCLUSIONS: In this preliminary analysis there was no difference in time to anion gap closure between the two groups. However, even at this early stage of subject recruitment, the 2BAG system shows more consistency in the time required to correct the metabolic derangements associated with DKA. These findings suggest that with increased recruitment, 2BAG may be a safe, efficient, and more efficacious method of treating adults with DKA. CLINICAL IMPLICATIONS: The consistency in time to treat DKA by the 2BAG protocol may be useful in predicting hospital length of stay and throughput required for patients admitted with DKA, and subsequently aid in anticipating bed availability and staffing requirements for hospital management. DISCLOSURES: No relevant relationships by Katherine Bruening, source=Web Response No relevant relationships by Chloe Castro, source=Web Response No relevant relationships by Kathleen Kerber, source=Web Response No relevant relationships by Vidya Krishnan, source=Web Response No relevant relationships by Toufik Madhun, source=Web Response No relevant relationships by John Thornton, source=Web Response Stockholder relationship with Pfizer, Johnson & Johnson Please note: $1001 - $5000 Added 03/15/2019 by Jessica Zangmeister, source=Web Response, value=Mutual funds