title: [A comparison of two systems for hydration of children with diabetic ketoacidosis. a randomized controlled trial].
abstract: 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.
authors.forename: Juan Pablo
authors.initials: JP
authors.lastname: Ferreira
authors.forename: Matias
authors.initials: M
authors.lastname: Penazzi
authors.forename: Macarena
authors.initials: M
authors.lastname: Taborda
authors.forename: Santiago
authors.initials: S
authors.lastname: Funes
authors.forename: Mauricio
authors.initials: M
authors.lastname: Villareal
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D016883:Diabetic Ketoacidosis / Q000188:drug therapy*; D004334:Drug Administration Schedule; D057239:Early Termination of Clinical Trials; D005260:Female; D005440:Fluid Therapy / Q000379:methods*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007223:Infant; D007328:Insulin / Q000008:administration & dosage*; D008297:Male; D016896:Treatment Outcome
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin