Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT01365793
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.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
17 Years
Study:
NCT01365793
Study Brief:
Protocol Section:
NCT01365793