Fluid Therapy and Cerebral Injury in Pediatric Diabetic Ketoacidosis

What is the trial about?

The purpose of this study is to learn about what causes brain swelling during DKA and if there is a relationship between brain swelling and intravenous fluid treatment.

Who can participate?

Children less than 18 years of age, in DKA, and their parents may be able to take part in this study.

What is involved?

• This study is part of a national study where 1,510 children are expected to be enrolled over 5 years; at the Nemours/Alfred I. duPont Hospital for Children we expect to enroll 20-30 patients a year.
• Participation in this study is for the first 24 hours of your child’s hospitalization (or until DKA resolves, whichever comes first) and at a follow-up visit three months from that day.
• This is a randomized control trial where participants will be assigned to one of four treatment groups. All groups will receive standard treatment for DKA, but fluids will be given at different rates and the amount of sodium (salt) in the fluids will vary in the different groups. 
• If you and your child take part in this research study, we will monitor him/her carefully to assess brain function and watch for any signs of brain swelling. This will involve testing for alertness by checking his/her movement, eye opening and speech. We will also perform brief memory tests during his/her hospital stay. At the follow-up visit we will perform a brief IQ test and some other memory tests, after which your child will be finished with the study.