Recruiting

Optic Ultrasound

Sponsor:

Children's Hospitals and Clinics of Minnesota

Code:

NCT02130180

Conditions

Diabetic Ketoacidosis

Uncontrolled Type 1 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 7 - 18

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Diabetic Ketoacidosis

Uncontrolled Type 1 Diabetes Mellitus

Study ID

NCT02130180

Start date

Apr, 2014

Status verified date

May, 2014

Completion date

Oct, 2015

Anticipated

Primary completion date

Oct, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

Ages 7-18 years English speaking

DKA group recruited from Children's ED. Criteria for DKA:

1. Hyperglycemia >200 mg/dL AND
2. Venous pH <7.30 AND/OR
3. Bicarbonate level <15 AND
4. 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:

1. Hemoglobin A1c <8% at time of clinic visit
2. No previous episodes of DKA other than at the time of diagnosis
3. Has never had a documented hemoglobin A1c >10%

Exclusion Criteria:

DKA and patients with T1DM and hyperglycemia without criteria for DKA

1. Treatment with more than 10 mL/kg IV fluids prior to transfer from outside hospital
2. Treatment with insulin prior to transfer from outside hospital
3. Patients with type 2 DM
4. Patients with Hyperosmolar Hyperglycemic Nonketotic State
5. Underlying neurologic condition predisposing to changes in ICP (hydrocephalus, ventriculoperitoneal shunt, Chiari I malformation, Chiari II malformation, pseudotumor cerebri, brain tumor)
6. Underlying condition predisposing to changes in intraocular pressure (glaucoma, eye trauma)

Well-controlled T1DM group with poorly controlled disease, defined as:

1. Hemoglobin A1c >8% OR
2. >1 previous episode of DKA, including DKA at time of diagnosis OR
3. Hemoglobin A1c documented >10% any time in the past

Study Design

Enrollment

108 participants

Anticipated

Interventions and Outcome Measures

Arms

ED T1DM and hyperglycemia without criteria for DKA

Well controlled T1DM

ED DKA

Primary outcome measure

  • Mean Optic Nerve Sheath Diameter [ Time Frame: 1 day; the day of the ED or clinic visit ]

Central Contacts and Locations

Central contacts

Locations

Children's Hospitals and Clinics of Minnesota

Recruiting

Minneapolis and St Paul, Minnesota, United States

Contacts

Principal Investigator:

Kelly Bergmann, MS, DO

More Information

Sponsor

Children's Hospitals and Clinics of Minnesota

Last update posted

Jul 30, 2015

Last verified

May, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospitals and Clinics of Minnesota on 2015-07-30.