Clinical Trials Logo

Clinical Trial Summary

The investigators will conduct a randomized controlled trial comparing four different intravenous (IV) fluid treatment protocols for pediatric diabetic ketoacidosis (DKA). Two rates of rehydration will be compared; a more rapid rate and a slower rate. Within each of these two basic rehydration protocols, the investigators will vary the type of rehydration fluid used (0.9% saline or 0.45% saline). The investigators will compare the different treatments by conducting assessments of neurological injury, by measuring the frequency of significant cerebral edema, and by measuring long-term neurocognitive function.

These studies will allow us to determine whether variations in IV fluid treatment protocols affect acute neurological outcomes of DKA. Additionally, they will provide important data regarding the impact of DKA and DKA treatment on long-term neurocognitive function in children. In this way, the investigators hope to identify a more ideal fluid management strategy for children with DKA.

Previous studies have suggested that DKA may cause blood flow to the brain to be reduced and that brain injury might result from this reduction in blood flow and/or the effects of re-establishment of normal blood flow during DKA treatment with insulin and iv fluids. The investigators hypothesize that more rapidly re-establishing normal blood flow to the brain during DKA, by giving fluids more rapidly and using fluids with a higher sodium (salt) content, will help to minimize brain injury caused by DKA.


Clinical Trial Description

These data will be compared to observational data from children with type 1 diabetes without DKA. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01365793
Study type Interventional
Source University of California, Davis
Contact
Status Completed
Phase Phase 3
Start date November 2010
Completion date January 2017

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Completed NCT03660189 - Two Bag System for Diabetic Ketoacidosis N/A
Terminated NCT03066440 - Double Blinded Randomized Control Trial of Types of IVF in Children With DKA Phase 4
Completed NCT04940897 - Use of Blood Ketone Meters to Improve Ambulance Hyperglycaemia Care N/A
Completed NCT02930044 - Early Subcutaneous Insulin Glargine Plus Standard of Care for Treatment of Diabetic Ketoacidosis N/A
Completed NCT04926740 - Intravenous Fluids in Adults With Diabetic Ketoacidosis in the Emergency Department N/A
Terminated NCT04567225 - Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management Phase 4
Completed NCT04017221 - Safety of Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors Among Patients With Type 2 Diabetes
Recruiting NCT03717896 - Thiamine as Adjunctive Therapy for Diabetic Ketoacidosis Phase 2
Terminated NCT02548494 - Early Administration of Long-acting Insulin Treatment of Diabetic Ketoacidosis in Pediatric Type 1 Diabetes N/A
Completed NCT02006342 - Effectiveness of Subcutaneous Glargine On The Time To Closure of The Anion Gap in Patients Presenting to the Emergency Department With Diabetic Keto-acidosis N/A
Completed NCT01753921 - Evaluation of a Non-invasive Brain Compliance Measurement Device
Completed NCT00426413 - Ketosis Prone Diabetes in African-Americans N/A
Not yet recruiting NCT05867797 - Risk Factors and Outcomes of Acute Kidney Injury in Patients With Diabetic Ketoacidosis at Sohag University Hospital.
Terminated NCT04234867 - Study to Explore the Effect of Dapagliflozin and Stress in Adolescent and Adult Subjects With Type 1 Diabetes (T1D) Phase 1
Not yet recruiting NCT05752279 - Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis Phase 3
Completed NCT04825639 - Identifying Risk Factors for Developing AKI in Sepsis
Recruiting NCT05155917 - Concurrent Subcutaneous Basal Insulin and Intravenous Insulin Pump in Hyperglycemic Crisis Patients Under Critical Care Phase 2
Recruiting NCT05383404 - Clinical and Laboratory Parameters Associated With Different Degrees of Dehydration Among Children With Diabetic Ketoacidosis
Completed NCT00629707 - Cerebral Edema in Pediatric Diabetic Ketoacidosis N/A