A randomized controlled trial of one bag vs. two bag system of fluid delivery in children with diabetic ketoacidosis: Experience from a developing country.

PURPOSE: To compare one vs. two bag system with respect to blood glucose variability (BGV), time for resolution of acidosis and incidence of hypoglycemia, hypokalemia, and cerebral edema in children with diabetic ketoacidosis (DKA).

MATERIAL AND METHODS: In an open labelled randomized controlled trial, thirty consecutive patients ≤12years with DKA were randomized to either one (n=15) or two bag (n=15) system of intravenous fluid delivery. The two bags had similar electrolyte but differing dextrose concentration (none vs. 12.5%) and changing the rate of fluid, delivered different dextrose concentrations. BGV was primary outcome while hypoglycemia (blood glucose, BG<50mg/dL), hypokalemia (serum potassium<3.5mEq/L), time to resolution of acidosis and cerebral edema were secondary outcomes.

RESULTS: The one and two bag systems had similar BGV parameters; median hourly absolute BG change (mg/dL) [44 (30-74.5) vs. 36 (31-49); p=0.54], mean of standard deviation of BG measurements [65.1 (25.1) vs. 65.5 (26.8); p=0.96] and median number of undesirable events (hourly blood sugar change ≥50mg/dL) [4.5 (1.75-6.0) vs. 5.0 (3.0-8.0); p=0.31]. The incidence of hypoglycemia [42.9% (n=6) vs. 26.7% (n=4); p=0.45] and hypokalemia [64% (n=9) vs. 67% (n=10); p=0.23], and mean (SD) time to resolution of acidosis [20.3 (14.8) and 20.3 (7.0); p=0.59] were similar in both the groups. None had cerebral edema.

CONCLUSIONS: The one and two bag systems were similar to each other with respect to BGV, incidence of complications and time to resolution of acidosis.