title: Pediatric diabetic ketoacidosis, fluid therapy, and cerebral injury: the design of a factorial randomized controlled trial.
abstract: Treatment protocols for pediatric diabetic ketoacidosis (DKA) vary considerably among centers in the USA and worldwide. The optimal protocol for intravenous (IV) fluid administration is an area of particular controversy, mainly in regard to possible associations between rates of IV fluid infusion and the development of cerebral edema (CE), the most common and the most feared complication of DKA in children. Theoretical concerns about associations between osmotic fluid shifts and CE have prompted recommendations for conservative fluid infusion during DKA. However, recent data suggest that cerebral hypoperfusion may play a role in cerebral injury associated with DKA. Currently, there are no existing data from prospective clinical trials to determine the optimal fluid treatment protocol for pediatric DKA. The Pediatric Emergency Care Applied Research Network FLUID (FLuid therapies Under Investigation in DKA) study is the first prospective randomized trial to evaluate fluid regimens for pediatric DKA. This 13-center nationwide factorial design study will evaluate the effects of rehydration rate and fluid sodium content on neurological status during DKA treatment, the frequency of clinically overt CE and long-term neurocognitive outcomes following DKA.
authors.affiliation: Department of Pediatrics, University of California Davis, School of Medicine, Davis, CA 95817, USA.
authors.forename: Nicole S
authors.initials: NS
authors.lastname: Glaser
authors.forename: Simona
authors.initials: S
authors.lastname: Ghetti
authors.forename: T Charles
authors.initials: TC
authors.lastname: Casper
authors.forename: J Michael
authors.initials: JM
authors.lastname: Dean
authors.forename: Nathan
authors.initials: N
authors.lastname: Kuppermann
mesh_terms: D000293:Adolescent; D035843:Biomedical Research; D001929:Brain Edema / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D002648:Child; D002675:Child, Preschool; D003072:Cognition Disorders / Q000209:etiology / Q000517:prevention & control*; D016883:Diabetic Ketoacidosis / Q000503:physiopathology / Q000628:therapy*; D005440:Fluid Therapy / Q000009:adverse effects*; D006801:Humans; D007262:Infusions, Intravenous; D007361:Intelligence Tests; D008569:Memory Disorders / Q000209:etiology / Q000517:prevention & control*; D009483:Neuropsychological Tests; D012008:Recurrence; D015532:Rehydration Solutions / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D012107:Research Design; D012964:Sodium / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D013223:Statistics as Topic; D014481:United States; D014883:Water-Electrolyte Imbalance / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*
chemical_list: D015532:Rehydration Solutions; D012964:Sodium
keywords: Cerebral Edema; DKA; brain injury