Cerebral Edema in Pediatric Diabetic Ketoacidosis
Märksõnad
Abstraktne
Kirjeldus
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.
Kuupäevad
Viimati kinnitatud: | 08/31/2012 |
Esmalt esitatud: | 03/03/2008 |
Hinnanguline registreerumine on esitatud: | 03/03/2008 |
Esmalt postitatud: | 03/05/2008 |
Viimane värskendus on esitatud: | 09/11/2012 |
Viimati värskendus postitatud: | 09/17/2012 |
Esimeste tulemuste esitamise kuupäev: | 06/17/2012 |
Esimeste kvaliteedikontrolli tulemuste esitamise kuupäev: | 08/08/2012 |
Esimeste postitatud tulemuste kuupäev: | 09/11/2012 |
Õppe tegelik alguskuupäev: | 05/31/2008 |
Eeldatav esmane lõpetamise kuupäev: | 02/28/2011 |
Eeldatav uuringu lõpetamise kuupäev: | 05/31/2011 |
Seisund või haigus
Sekkumine / ravi
Other: intravenous fluid treatment
Faas
Käerühmad
Arm | Sekkumine / ravi |
---|---|
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. | |
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. |
Abikõlblikkuse kriteeriumid
Õppimiseks sobivad vanused | 8 Years To 8 Years |
Uuringuks kõlblikud sood | All |
Võtab vastu tervislikke vabatahtlikke | Jah |
Kriteeriumid | 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 |
Tulemus
Esmased tulemusnäitajad
1. Cerebral Edema Measured by MR Imaging (Apparent Diffusion Coefficient) [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]
Sekundaarsed tulemusmõõdud
1. 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]