Cerebral Edema in Pediatric Diabetic Ketoacidosis

Diabetic Ketoacidosis Clinical Trial

Official title:

Cerebral Edema in Pediatric Diabetic Ketoacidosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00629707
• Other study ID #: R01NS048610
• Secondary ID: R01NS052619-01R0
• Status: Completed
• Phase: N/A
• First received: March 4, 2008
• Last updated: September 12, 2012
• Start date: June 2008
• Est. completion date: June 2011

Study information

• Verified date: September 2012
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to compare two different rates of fluid administration during diabetic ketoacidosis (DKA) treatment in children to determine which fluid administration rate is more beneficial for brain metabolism and for preventing or decreasing brain swelling during DKA.

Description:

Cerebral edema (swelling of the brain) is the most frequent serious complication of diabetic ketoacidosis (DKA) in children. The cause of cerebral edema during DKA is not well understood. Recent studies suggest that it may result from lack of adequate blood flow to the brain during DKA, before treatment starts. Brain injury, resulting in edema, may occur before treatment because of lack of adequate blood flow to the brain and additional injury may occur when adequate blood flow is re-established during treatment (called reperfusion injury). Because additional injury may occur during treatment, it is important to understand whether the rate of administration of intravenous fluids, and, therefore, the speed of reperfusion of the brain, is related to the degree of brain swelling and injury. Most current treatment protocols indicate that intravenous fluids should be administered slowly, but it may be possible that brain injury and swelling might be lessened if adequate blood flow is established more quickly.

In this study, researchers will use magnetic resonance (MR) imaging to compare two different rates of fluid administration during DKA treatment in children. The investigators will use MR imaging to measure brain swelling and metabolism at three time points—twice during treatment and once after recovery from DKA—and will compare these measurements to determine which fluid administration rate has more beneficial effects on brain metabolism and brain swelling.

The study's researchers hypothesize that more rapid re-establishment of blood flow to the brain (via more rapid administration of intravenous fluids) will result in less brain swelling and injury than slower rehydration with delayed re-establishment of adequate brain blood flow will.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• age 8-18 years

• diagnosis of diabetic ketoacidosis

• able to cooperate with MR scanning

Exclusion Criteria:

• pre-existing cerebral injury or brain structural abnormality

• dental hardware or other metal devices which would interfere with MR imaging

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Edema
• Diabetic Ketoacidosis

Intervention

Other:
• intravenous fluid treatment
infusion of intravenous fluids (0.9% saline and 0.45% saline)

Locations

Country	Name	City	State
United States	University of California, Davis Medical Center, 2315 Stockton Blvd	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral Edema Measured by MR Imaging (Apparent Diffusion Coefficient)	In both groups, brain Apparent Diffusion Coefficient (ADC) measures at 3-6 hours and 9-12 hours after beginning DKA treatment were averaged to determine overall brain ADC during DKA treatment. The brain ADC indicates the distribution of water in the brain and is an indicator of brain swelling (edema). The overall brain ADC values during DKA treatment were compared with the brain ADC measured after recovery to assess the degree of brain edema formation during DKA treatment. The difference in brain ADC, calculated as the averaged treatment values minus the recovery value, was used as the main outcome measure to indicate the degree of brain edema formation	twice during DKA treatment, once at 3-6 hours and at 9-12 after treatment. A normal comparison measurement will be done after recovery from DKA, at least 72 hours after treatment	No
Secondary	Brain NAA/Creatine Ratio & Brain Lactate Measured by MR Spectroscopy, Cerebral Blood Flow & Oxygen Saturation Measured by MR Perfusion Weighted Imaging & Near Infrared Spectroscopy, Mental Status Evaluated by Glasgow Coma Scale Scores.		twice during DKA treatment, once at 3-6 hours and at 9-12 after treatment. A normal comparison measurement will be done after recovery from DKA, at least 72 hours after treatment	No