Trial record 7 of 15 for:    "Diabetic Ketoacidosis"

DKA Optic Ultrasound (DKA Optic US)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Children's Hospitals and Clinics of Minnesota
Sponsor:
Information provided by (Responsible Party):
Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier:
NCT02130180
First received: April 25, 2014
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

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
Diabetic Ketoacidosis
Uncontrolled Type 1 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Measurement of the Optic Nerve Sheath Diameter by Optic Ultrasound in Diabetic Ketoacidosis and the Relationship to Cerebral Edema

Resource links provided by NLM:


Further study details as provided by Children's Hospitals and Clinics of Minnesota:

Primary Outcome Measures:
  • Mean Optic Nerve Sheath Diameter [ Time Frame: 1 day; the day of the ED or clinic visit ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 108
Study Start Date: April 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
ED T1DM and hyperglycemia without criteria for DKA
Well controlled T1DM
ED DKA

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02130180

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

Locations
United States, Minnesota
Children's Hospitals and Clinics of Minnesota Recruiting
Minneapolis and St Paul, Minnesota, United States
Contact: Kelly Bergmann, MS, DO    612-813-6843    kelly.bergmann@childrensmn.org   
Principal Investigator: Kelly Bergmann, MS, DO         
Sponsors and Collaborators
Children's Hospitals and Clinics of Minnesota
Investigators
Principal Investigator: Kelly Bergmann, MS, DO Children's Hospitals and Clinics of Minnesota
  More Information

No publications provided

Responsible Party: Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT02130180     History of Changes
Other Study ID Numbers: 1402-020
Study First Received: April 25, 2014
Last Updated: May 1, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetic Ketoacidosis
Diabetes Mellitus
Diabetes Mellitus, Type 1
Ketosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Acidosis
Acid-Base Imbalance
Diabetes Complications

ClinicalTrials.gov processed this record on August 26, 2014