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ClinicalTrials.gov Identifier: NCT02130180
Verified May 2014 by Children's Hospitals and Clinics of Minnesota. Recruitment status was: Recruiting
Diabetic ketoacidosis (DKA) is a complication of type 1, or "insulin-dependent," diabetes (T1DM) and is defined by a high blood glucose level (over 200 mg/dL) coupled with severe acidosis. In this state the body breaks down fat tissue for adequate energy production. This results in ketone and acid production, and ultimately DKA. Cerebral edema (CE), or "brain swelling," can also occur with severe DKA. Current evaluation for DKA-related CE necessitates a high index of clinical suspicion and often times such patients receive advanced brain imaging such as computed tomography (CT) scans.Ocular sonography (ultrasound) is an alternative imaging technique that can provide immediate diagnostic capability at the bedside and minimize radiation exposure. This technique has been used to rapidly and accurately detect increased brain swelling through measurement of the optic nerve sheath diameter (ONSD) in a number of clinical situations including pediatric head trauma, hydrocephalus and ventriculoperitoneal shunt malfunctions, and altitude sickness in adults. Investigators plan to conduct a prospective study including children aged 7-18 years. The objective of this study is to assess the utility of sonographic measurements of the ONSD as a tool for identification of DKA-related CE.
Condition or disease
Diabetic KetoacidosisUncontrolled Type 1 Diabetes Mellitus
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Ages Eligible for Study:
7 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
We will conduct a cross-sectional study of pediatric patients aged 7-18 years. This study will involve recruitment of patients from both the Endocrinology Clinic and the ED. We will recruit patients from the Children's Endocrinology Clinic with well-controlled T1DM, defined as having a hemoglobin A1c <8% at time of the clinic visit, no previous episodes of DKA other than at the time of diagnosis, and no previous hemoglobin A1c values >10%. This study will also involve recruitment of two subsets of patients from the Children's ED: those with DKA and those with T1DM and hyperglycemia without criteria for DKA.
Ages 7-18 years English speaking
DKA group recruited from Children's ED. Criteria for DKA:
Hyperglycemia >200 mg/dL AND
Venous pH <7.30 AND/OR
Bicarbonate level <15 AND
Either positive urine or serum ketones
T1DM and hyperglycemia without criteria for DKA (recruited from Children's ED). Criteria for inclusion:
1. Hyperglycemia (>200 mg/dL) not meeting above criteria for DKA
Well-controlled T1DM control group (recruited from Children's Endocrinology Clinic). Criteria for inclusion:
Hemoglobin A1c <8% at time of clinic visit
No previous episodes of DKA other than at the time of diagnosis
Has never had a documented hemoglobin A1c >10%
DKA and patients with T1DM and hyperglycemia without criteria for DKA
Treatment with more than 10 mL/kg IV fluids prior to transfer from outside hospital
Treatment with insulin prior to transfer from outside hospital
Patients with type 2 DM
Patients with Hyperosmolar Hyperglycemic Nonketotic State
Underlying neurologic condition predisposing to changes in ICP (hydrocephalus, ventriculoperitoneal shunt, Chiari I malformation, Chiari II malformation, pseudotumor cerebri, brain tumor)
Underlying condition predisposing to changes in intraocular pressure (glaucoma, eye trauma)
Well-controlled T1DM group with poorly controlled disease, defined as:
Hemoglobin A1c >8% OR
>1 previous episode of DKA, including DKA at time of diagnosis OR
Hemoglobin A1c documented >10% any time in the past