Randomized Control Trial of Fluid Therapy for Pediatric Diabetic Ketoacidosis
Cerebral Edema, Diabetic Ketoacidosis
About this trial
This is an interventional treatment trial for Cerebral Edema focused on measuring cerebral edema, diabetic ketoacidosis, pediatric diabetes, fluid therapy
Eligibility Criteria
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.
Sites / Locations
- University of California, Davis
- Children's Hospital Colorado
- Alfred I. duPont Hospital for Children
- Children's National Medical Center
- Ann & Robert Lurie Children's Hospital of Chicago
- Children's Hospital Boston
- Washington University & St. Louis Children's Hospital
- Columbia University
- Nationwide Children's Hospital
- The Children's Hospital of Philadelphia
- Hasbro Children's Hospital/Rhode Island Hospital
- Texas Children's Hospital
- University of Utah
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Rapid rehydration using 0.45% saline replacement fluid
Rapid rehydration using 0.9% saline replacement fluid
Slower rehydration using 0.45% saline intravenous fluid
Slower rehydration using 0.9% saline intravenous fluid
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.
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.
This arm will involve slower rehydration (assumed 5% fluid deficit and no additional fluid bolus) with 0.45% saline used as the replacement fluid.
This arm will involve slower rehydration (assumed 5% fluid deficit and no additional fuid bolus) with 0.9% saline used as the replacement fluid.