[A comparison of two systems for hydration of children with diabetic ketoacidosis. a randomized controlled trial].

Background: Treatment of diabetic ketoacidosis (DKA) requires hourly controls of blood glucose, which define changes in the intravenous glucose and insulin administration. Every change requires preparing a new solution, wasting time and allowing errors. The two bag system (same electrolytes composition, but one with and the other without glucose) allows immediate changes in glucose administration rate, just by changing the solutions drip.

Objective: To compare the time needed to reach stabilization of patients with DKA using two different hydration systems: the traditional one (1 glucose/electrolyte solution) vs. the alternative one (2 glucose/electrolyte solutions -"two bag system"-).

Methods: Randomized controlled trial, including children aged 1 to 18 years, hospitalized for DKA (glycemia >200 mg/dl, pH <7.3, bicarbonate <15 mmol/L, glycosuria and ketonuria). After initial emergency re-hydration, patients were randomized to one of the 2 hydration systems (traditional or alternative), using it until patient stabilization (glycemia ≤250 mg/dl, pH ≥ 7.3, bicarbonate ≥ 15 mmol/L); the time required to reach stabilization was the outcome variable.

Results: After enrolling 12 of the 32 planned subjects (6 in each group) Data Monitoring Committee performed a scheduled interim analysis, finding that the time required to reach stabilization was significantly shorter using the alternative system (9.8±1.16 hs vs. 13.3±2.8 hs; p=0.018). Because of the magnitude of this finding, the Ethics Committee decided to terminate the study.