Clinical trial NCT01365793
Conditions: Cerebral Edema Diabetic Ketoacidosis
Keywords: cerebral edema diabetic ketoacidosis pediatric diabetes fluid therapy
Sponsor: University of California, Davis
Start date: 2010-11-01; Completion date: 2017-01-01
Enrollment: 1389 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief 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.

Arms: arm 1: This arm will involve more rapid intravenous fluid treatment which will include a second 10cc/Kg bolus of 0.9% saline and assume a 10% fluid deficit. 0.45% saline will be used as the replacement fluid for this arm. arm 2: This arm will involve more rapid intravenous fluid treatment which will include a second 10cc/Kg bolus of 0.9% saline and assume a 10% fluid deficit. 0.9% saline will be used as the replacement fluid. arm 3: This arm will involve slower rehydration (assumed 5% fluid deficit and no additional fluid bolus) with 0.45% saline used as the replacement fluid. arm 4: This arm will involve slower rehydration (assumed 5% fluid deficit and no additional fuid bolus) with 0.9% saline used as the replacement fluid.
Interventions: intervention 1: 0.45% saline replacement fluid intervention 2: 0.9% saline replacement fluid intervention 3: 0.45% saline intravenous fluid intervention 4: 0.9% saline Intravenous fluid
Intervention descriptions: intervention 1: 10cc/Kg bolus of 0.9% saline followed by 0.45% saline used as the replacement fluid intervention 2: 10cc/Kg bolus of 0.9% saline followed by 0.9% saline used as the replacement fluid. intervention 3: 0.45% saline fluid intervention 4: 0.9% saline fluid

Protocol documents: