DKA Optic Ultrasound

Status unconfirmed

Conditions studied: Diabetic Ketoacidosis, Uncontrolled Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT02130180

Run by

Children's Hospitals and Clinics of Minnesota

People needed

108

Starts

2014-04-01

Expected to finish

2015-10-01

Last updated by the study team

2015-07-30

Who can join

Age: 7 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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%

You may not qualify if…

• 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

Where it is running

• Children's Hospitals and Clinics of Minnesota — Minneapolis and Saint Paul, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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