Cerebral Edema in Pediatric Diabetic Ketoacidosis
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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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Cerebral Edema in Pediatric Diabetic Ketoacidosis |
- Cerebral Edema Measured by MR Imaging (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 ]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
- 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 ]
| Enrollment: | 20 |
| Study Start Date: | June 2008 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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.
|
Other: intravenous fluid treatment
infusion of intravenous fluids (0.9% saline and 0.45% saline)
|
|
Active Comparator: 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.
|
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 |
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| United States, California | |
| University of California, Davis Medical Center, 2315 Stockton Blvd | |
| Sacramento, California, United States, 95817 | |
| Principal Investigator: | Nicole Glaser, MD | University of California, Davis |
More Information
No publications provided
| Responsible Party: | University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT00629707 History of Changes |
| Other Study ID Numbers: | R01NS048610, R01NS052619-01, R01NS052592-01 |
| Study First Received: | March 4, 2008 |
| Results First Received: | June 18, 2012 |
| Last Updated: | September 12, 2012 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by University of California, Davis:
|
diabetic ketoacidosis DKA cerebral edema brain edema |
Additional relevant MeSH terms:
|
Brain Edema Diabetic Ketoacidosis Edema Ketosis Acidosis Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Acid-Base Imbalance Metabolic Diseases Diabetes Mellitus Glucose Metabolism Disorders Diabetes Complications Endocrine System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013