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Diabetic KetoacidosisDKA Optic USNCT02130180

DKA Optic Ultrasound

An observational study of Diabetic Ketoacidosis and Uncontrolled Type 1 Diabetes Mellitus, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 to 18 years
How many people
108 participants
Where
1 siteUnited States
Study dates
Apr 2014to Oct 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: 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.

Who may be able to join

  • 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
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  • 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%

Who cannot join

  • 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)
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Kelly Bergmann, MS, DO contact

612-813-6843

kelly.bergmann@childrensmn.org

United States1 site, 1 recruiting
  • Children's Hospitals and Clinics of Minnesota

    Minneapolis and Saint Paul, Minnesota

    Kelly Bergmann, MS, DO, 612-813-6843, kelly.bergmann@childrensmn.org

    Kelly Bergmann, MS, DO

    Recruiting

Other trials in United States

About this study

Official title: Measurement of the Optic Nerve Sheath Diameter by Optic Ultrasound in Diabetic Ketoacidosis and the Relationship to Cerebral Edema

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.

Read the detailed description

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. Children with T1DM lack adequate insulin production. Without insulin, glucose cannot be used by cells to produce energy and blood glucose levels increase. As a result, the body breaks down fat tissue for adequate energy production. This results in ketone and acid production, and ultimately DKA. Often times DKA is present at the time of diabetes diagnosis. Recent estimates suggest that nearly 30% of children that present with DKA are newly diagnosed with diabetes. DKA can also occur as a result of poorly controlled T1DM or poor adherence to insulin therapy. It is common for such patients to have recurrent episodes of DKA, which may lead to permanent brain injury.

Cerebral edema (CE), or "brain swelling," can also occur with severe DKA. It is unclear what causes CE in children with DKA. Proposed mechanisms include changes in blood flow to the brain, inflammatory mediation, and alteration in the intracellular and extracellular fluid composition in the brain. CE can be "clinically apparent" or "subclinical" in terms of symptomatology. Children with clinically apparent DKA-related CE present with neurologic deficits and altered mental status. These children are at risk for herniation of the brain stem due to elevated pressures in and around the brain, and ultimately death. The neurologic manifestations of clinically apparent DKA-related CE typically occur 4-12 hours after the initiation of medical therapy. However, cases have been reported to occur prior to initiation of therapy. Although clinically apparent DKA-related CE is rare, occurring in 0.5-1% of children with DKA, subclinical DKA-related CE is much more common with estimates suggesting that up to 54% of children with DKA have underlying CE that goes clinically undetected. Early identification of both clinically apparent and subclinical DKA-related CE is critical as the time between initial neurologic symptoms and clinical deterioration can be as little as 3 hours. Moreover, early identification of subclinical DKA-related CE may lead to differences in medical therapy.

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. While CT scans can identify CE, this imaging modality exposes patients to ionizing radiation, is expensive, and may take considerable time in some instances. Moreover, CE can occur in the absence of acute change on CT and some patients with subclinical CE may go unidentified. Magnetic resonance imaging (MRI) has been used to identify subclinical DKA-related CE, however this is often time-consuming, expensive, requires sedation, or may be unavailable at some centers. 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.

It is believed, no study has used ocular ultrasound to examine the ONSD in the setting of diabetes or DKA for identification of clinically apparent or subclinical CE. It is unclear if patients with T1DM have a fundamentally different baseline ONSD measurement compared to described normal values. It is also unclear how the ONSD varies during times of diabetes-related illness, such as high blood glucose levels without criteria for DKA compared to unequivocal DKA.

Investigators plan to conduct a prospective study including children aged 7-18 years that present to the Children's Endocrinology Clinic and Children's Emergency Department. 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. Specifically, the primary aim of this study is to measure and compare the mean ONSD in children with well-controlled T1DM to those presenting to the Emergency Department (ED) with DKA and to those presenting to the ED with T1DM and hyperglycemia without criteria for DKA. Investigators hypothesize that the mean ONSD measurement is smaller in children with well-controlled T1DM compared to children presenting to the ED with DKA and compared to children with T1DM and hyperglycemia without criteria for DKA. Secondarily, investigators aim to compare the mean ONSD in children presenting to the ED with DKA to those presenting to the ED with T1DM and hyperglycemia without criteria for DKA. The study team hypothesizes that the mean ONSD measurement is larger in children presenting to the ED with DKA compared children presenting with T1DM and hyperglycemia without criteria for DKA.

Medical subject headings
Diabetic Ketoacidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02130180
Study groupRoleWhat they receive
ED T1DM and hyperglycemia without criteria for DKANot described
Well controlled T1DMNot described
ED DKANot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Optic Nerve Sheath Diameter

    Measure and compare the mean ONSD in children with well-controlled T1DM to those presenting to the ED with DKA and to those presenting to the ED with T1DM and hyperglycemia without criteria for DKA.

    Measured: 1 day; the day of the ED or clinic visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionOct 2015 (estimated)
  4. Study completionOct 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02130180
Sponsor's protocol ID
1402-020
Acronym
DKA Optic US
Status last verified
May 2014
First submitted
25 Apr 2014
Last updated
30 Jul 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetic Ketoacidosis and Uncontrolled Type 1 Diabetes Mellitus, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kelly Bergmann, MS, DO (612-813-6843, kelly.bergmann@childrensmn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Optic Nerve Sheath Diameter (time frame: 1 day; the day of the ED or clinic visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.

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