Cerebral Edema in Pediatric Diabetic Ketoacidosis - Clinical Trials for Diabetic Coma

Cerebral Edema in Pediatric Diabetic Ketoacidosis
November 19, 2008
clinicaltrials.gov

This study is currently recruiting participants.
Verified by National Institute of Neurological Disorders and Stroke (NINDS), September 2008

Sponsors and Collaborators: University of California, Davis
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT00629707
Purpose

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.

Condition Intervention
Diabetic Ketoacidosis
Other: intravenous fluid treatment

MedlinePlus related topics: Edema

Drug Information available for: Sodium chloride

U.S. FDA Resources

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
Official Title: Cerebral Edema in Pediatric Diabetic Ketoacidosis

Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):

Primary Outcome Measures:

* cerebral edema measured by MR imaging (total brain water and apparent diffusion coefficient) [ Time Frame: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

* 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. [ Time Frame: 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Active Comparator
infusion of intravenous fluids at a slower rate during DKA treatment
Other: intravenous fluid treatment
infusion of intravenous fluids (0.9% saline and 0.45% saline)
2: Active Comparator
infusion of intravenous fluids at a more rapid rate during DKA treatment
Other: intravenous fluid treatment
infusion of intravenous fluids (0.9% saline and 0.45% saline)

Detailed 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.
Eligibility
Ages Eligible for Study: 8 Years to 18 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00629707

Contacts
Contact: Nicole Glaser, MD 916-734-0406

Locations
United States, California
University of California, Davis Medical Center, 2315 Stockton Blvd Recruiting
Sacramento, California, United States, 95817
Contact: Nicole Glaser, MD 916-734-0406 nsglaser@ucdavis.edu

Sponsors and Collaborators
University of California, Davis
National Institute of Neurological Disorders and Stroke (NINDS)

Investigators
Principal Investigator: Nicole Glaser, MD University of California, Davis

More Information

Responsible Party: University of California, Davis, School of Medicine ( Nicole Glaser, MD, Associate Professor of Pediatrics )
Study ID Numbers: R01NS048610, R01NS052619-01, R01NS052592-01, 2CARE-01.00
First Received: March 4, 2008
Last Updated: September 9, 2008
ClinicalTrials.gov Identifier: NCT00629707
Health Authority: United States: Federal Government; United States: University of California, Davis Human Subjects Review Committee

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
diabetic ketoacidosis
DKA
cerebral edema
brain edema

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus
Edema
Central Nervous System Diseases
Endocrine System Diseases
Brain Edema
Brain Diseases

Acidosis
Diabetic Ketoacidosis
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder
Diabetes Complications

Additional relevant MeSH terms:
Nervous System Diseases
Acid-Base Imbalance