Pediatric Diabetic Ketoacidosis (DKA) Fluid Therapy RCT (FLUID)

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Pediatric Diabetic Ketoacidosis (DKA) Fluid Therapy RCT (FLUID)

Health Condition: DKA-related cerebral injury
Health Impact Domain: Mortality, Safety of care, Effectiveness of care, Readmissions, Patient experience, Timeliness of care, Decreased incidence/length of hospitalization, Creation of decision tool, Drug stewardship

Summary

Preliminary data strongly support the concept that diabetic ketoacidosis (DKA) related cerebral injury and subsequent edema may occur as a spectrum of severity. Although only a minority of children develop clinically-overt DKA-related cerebral injury of sufficient severity for obvious, profound neurological dysfunction, a much larger percentage may have subtle cerebral injury. The impact of variation in DKA treatment protocols on this cerebral injury is unknown and arguments for either slower or faster fluid treatment protocols can be made.

This study is a factorial-design, randomized controlled trial comparing four fluid treatment protocols for pediatric DKA. Two rates of rehydration will be compared; a more rapid rate, designed to promote faster reperfusion of brain tissue and a slower rate, geared toward more gradual reperfusion. Within each of these two basic rehydration schemes, we will vary the type of rehydration fluid used (0.9% saline or 0.45% saline). We will compare treatment arms using a comprehensive set of assessments for neurological injury including measurements of subtle neurological dysfunction during DKA treatment (in addition to recording the frequency of acute, clinically-overt cerebral edema) and measures of long-term neurocognitive function. These studies will not only allow us to determine whether variations in fluid treatment protocols affect acute neurological outcomes of DKA, but also will provide important additional data regarding the impact of DKA and DKA treatment on long-term neurocognitive function in children. In this way, we hope to identify a more ideal fluid management strategy for children with DKA. The anticipated enrollment period is from Fall 2010-2015. This project is co-funded by NICHD.

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