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Sponsors and Collaborators: |
University of California, Davis National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00629707 |
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 |
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Diabetic Ketoacidosis |
Other: intravenous fluid treatment |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study |
Official Title: | Cerebral Edema in Pediatric Diabetic Ketoacidosis |
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 |
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1: Active Comparator
infusion of intravenous fluids at a slower rate during DKA treatment
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Other: intravenous fluid treatment
infusion of intravenous fluids (0.9% saline and 0.45% saline)
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2: Active Comparator
infusion of intravenous fluids at a more rapid rate during DKA treatment
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Other: intravenous fluid treatment
infusion of intravenous fluids (0.9% saline and 0.45% saline)
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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.
Ages Eligible for Study: | 8 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Nicole Glaser, MD | 916-734-0406 | nsglaser@ucdavis.edu |
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 |
Principal Investigator: | Nicole Glaser, MD | University of California, Davis |
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 |
Study 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 |
diabetic ketoacidosis DKA cerebral edema brain edema |
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 |
Nervous System Diseases Acid-Base Imbalance |