N/A N=20 Randomized Single-blind Treatment

Cerebral Edema in Pediatric Diabetic Ketoacidosis

Diabetic Ketoacidosis

Bottom Line

View on ClinicalTrials.gov: NCT00629707 ↗

Enrolled (actual)

Serious AEs

5.0%

Results posted

Sep 2012

Primary outcome: Primary: Cerebral Edema Measured by MR Imaging (Apparent Diffusion Coefficient) — 36; 48 mm^2/sec

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: intravenous fluid treatment (Other)
Age: Pediatric, Adult · 8+ yrs
Sex: All
Sponsor: University of California, Davis
Primary completion: Mar 2011

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.	—	—

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.

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

View full record on ClinicalTrials.gov →

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.