Randomized Control Trial of Fluid Therapy for Pediatric Diabetic Ketoacidosis

Status:	Completed
Conditions:	Cardiology, Neurology
Therapuetic Areas:	Cardiology / Vascular Diseases, Neurology
Healthy:	No
Age Range:	Any - 17
Updated:	6/27/2018
Start Date:	November 2010
End Date:	January 2017

Fluid Therapy and Cerebral Injury in Pediatric Diabetic Ketoacidosis

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.

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

Inclusion Criteria:

- must present or be transferred to a participating emergency department

- age less than 18 years

- diagnosis of DKA

- serum glucose or fingerstick glucose concentration >300 mg/dL

- venous pH < 7.25 OR serum bicarbonate concentration < 15 mmol/L.

Exclusion Criteria:

- patients with underlying neurological disorders or neurocognitive deficits which would
affect either mental status testing during treatment or subsequent neurocognitive
testing after recovery

- patients who present with concomitant alcohol or drug use, head trauma, meningitis or
other conditions which might affect neurological function

- patients transferred to one of the participating emergency departments after
initiation of DKA treatment other than one 10cc/kg intravenous bolus of 0.9% saline

- patients who are known to be pregnant at time of ED evaluation

- patients who have been enrolled in this study twice previously

- patients for whom the treating physician believed a specific fluid and electrolyte
regimen was warranted

- patients for whom informed consent could not be obtained within 1 hour after
completion of the initial fluid bolus, or within 2 hours from initiation of fluids,
whichever is longer

- Patients who have been receiving IV fluids at a maintenance rate or greater (defined
by the 4-2-1 rule) for more than two hours; OR

- Patients for whom it has been more than four hours since DKA therapy (IV fluids, IV
bolus, or IV insulin) began; OR

- Patients who have been given hyperosmolar therapy (i.e. mannitol or 3% normal saline)
prior to or since arriving at one of the participating PECARN emergency departments;
OR

- Patients for whom the treating physician intends to immediately administer
hyperosmolar therapy (i.e. mannitol or 3% normal saline); OR

- Patients whose baseline GCS is 11 or less.

We found this trial at

sites

Children's Hospital of Philadelphia

South 34th Street
Philadelphia, Pennsylvania 19104

215-590-1000