Study Results
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View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2008-06-30
2011-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Slower infusion rate: Patients in this arm will receive an initial intravenous fluid bolus of 10cc/Kg followed by rehydration calculated to replace a deficit of 7.5% of body weight over 48 hours.
intravenous fluid treatment
infusion of intravenous fluids (0.9% saline and 0.45% saline)
2
More rapid infusion: Patients in this arm will receive an initial bolus of 20 cc/Kg of intravenous fluids followed by replacement of an estimated deficit of 10% of body weight over 36 hours plus replacement of 1/2 of urine output volume.
intravenous fluid treatment
infusion of intravenous fluids (0.9% saline and 0.45% saline)
Interventions
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intravenous fluid treatment
infusion of intravenous fluids (0.9% saline and 0.45% saline)
Eligibility Criteria
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Inclusion Criteria
* diagnosis of diabetic ketoacidosis
* able to cooperate with MR scanning
Exclusion Criteria
* dental hardware or other metal devices which would interfere with MR imaging
8 Years
18 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of California, Davis
OTHER
Responsible Party
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Principal Investigators
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Nicole Glaser, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
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University of California, Davis Medical Center, 2315 Stockton Blvd
Sacramento, California, United States
Countries
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References
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Trainor JL, Glaser NS, Tzimenatos L, Stoner MJ, Brown KM, McManemy JK, Schunk JE, Quayle KS, Nigrovic LE, Rewers A, Myers SR, Bennett JE, Kwok MY, Olsen CS, Casper TC, Ghetti S, Kuppermann N; Pediatric Emergency Care Applied Research Network (PECARN) FLUID Study Group. Clinical and Laboratory Predictors of Dehydration Severity in Children With Diabetic Ketoacidosis. Ann Emerg Med. 2023 Aug;82(2):167-178. doi: 10.1016/j.annemergmed.2023.01.001. Epub 2023 Apr 5.
Rewers A, Kuppermann N, Stoner MJ, Garro A, Bennett JE, Quayle KS, Schunk JE, Myers SR, McManemy JK, Nigrovic LE, Trainor JL, Tzimenatos L, Kwok MY, Brown KM, Olsen CS, Casper TC, Ghetti S, Glaser NS; Pediatric Emergency Care Applied Research Network (PECARN) FLUID Study Group. Effects of Fluid Rehydration Strategy on Correction of Acidosis and Electrolyte Abnormalities in Children With Diabetic Ketoacidosis. Diabetes Care. 2021 Sep;44(9):2061-2068. doi: 10.2337/dc20-3113. Epub 2021 Jun 29.
Kuppermann N, Ghetti S, Schunk JE, Stoner MJ, Rewers A, McManemy JK, Myers SR, Nigrovic LE, Garro A, Brown KM, Quayle KS, Trainor JL, Tzimenatos L, Bennett JE, DePiero AD, Kwok MY, Perry CS 3rd, Olsen CS, Casper TC, Dean JM, Glaser NS; PECARN DKA FLUID Study Group. Clinical Trial of Fluid Infusion Rates for Pediatric Diabetic Ketoacidosis. N Engl J Med. 2018 Jun 14;378(24):2275-2287. doi: 10.1056/NEJMoa1716816.
Other Identifiers
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