NCT01365793

Randomized Control Trial of Fluid Therapy for Pediatric Diabetic Ketoacidosis

Fluid Therapy and Cerebral Injury in Pediatric Diabetic Ketoacidosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,389 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

The investigators will conduct a randomized controlled trial comparing four different intravenous (IV) fluid treatment protocols for pediatric diabetic ketoacidosis (DKA). Two rates of rehydration will be compared; a more rapid rate and a slower rate. Within each of these two basic rehydration protocols, the investigators will vary the type of rehydration fluid used (0.9% saline or 0.45% saline). The investigators will compare the different treatments by conducting assessments of neurological injury, by measuring the frequency of significant cerebral edema, and by measuring long-term neurocognitive function. These studies will allow us to determine whether variations in IV fluid treatment protocols affect acute neurological outcomes of DKA. Additionally, they will provide important data regarding the impact of DKA and DKA treatment on long-term neurocognitive function in children. In this way, the investigators hope to identify a more ideal fluid management strategy for children with DKA. Previous studies have suggested that DKA may cause blood flow to the brain to be reduced and that brain injury might result from this reduction in blood flow and/or the effects of re-establishment of normal blood flow during DKA treatment with insulin and iv fluids. The investigators hypothesize that more rapidly re-establishing normal blood flow to the brain during DKA, by giving fluids more rapidly and using fluids with a higher sodium (salt) content, will help to minimize brain injury caused by DKA.

Detailed description

These data will be compared to observational data from children with type 1 diabetes without DKA.

Conditions

• Cerebral Edema
• Diabetic Ketoacidosis

Interventions

Type	Name	Description
DRUG	0.45% saline replacement fluid	10cc/Kg bolus of 0.9% saline followed by 0.45% saline used as the replacement fluid
DRUG	0.9% saline replacement fluid	10cc/Kg bolus of 0.9% saline followed by 0.9% saline used as the replacement fluid.
DRUG	0.45% saline intravenous fluid	0.45% saline fluid
DRUG	0.9% saline Intravenous fluid	0.9% saline fluid

Timeline

• Start date: 2010-11-01
• Primary completion: 2016-09-01
• Completion: 2017-01-01
• First posted: 2011-06-03
• Last updated: 2018-06-25
• Results posted: 2018-06-25

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study