N/A
Completed N=20
Cerebral Edema in Pediatric Diabetic Ketoacidosis
Source: ClinicalTrials.gov NCT00629707 ↗Enrolled (actual)
20
Serious AEs
5.0%
Results posted
Sep 2012
Primary outcomePrimary: Cerebral Edema Measured by MR Imaging (Apparent Diffusion Coefficient) — 36; 48 mm^2/sec
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cerebral Edema Measured by MR Imaging (Apparent Diffusion Coefficient) |
36; 48 | — |
| SECONDARY 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. |
— | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00629707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.