Randomized Control Trial of Fluid Therapy for Pediatric Diabetic Ketoacidosis
Public ClinicalTrials.gov record NCT01365793. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Fluid Therapy and Cerebral Injury in Pediatric Diabetic Ketoacidosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01365793
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,389 participants
Conditions and interventions
Conditions
Interventions
- 0.45% saline replacement fluid Drug
- 0.9% saline replacement fluid Drug
- 0.45% saline intravenous fluid Drug
- 0.9% saline Intravenous fluid Drug
Drug
Eligibility (public fields only)
- Age range
- Up to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2010
- Primary completion
- Aug 31, 2016
- Completion
- Dec 31, 2016
- Last update posted
- Jun 24, 2018
2010 – 2017
United States locations
- U.S. sites
- 13
- U.S. states
- 13
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, Davis | Sacramento | California | 95817 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Alfred I. duPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Ann & Robert Lurie Children's Hospital of Chicago | Chicago | Illinois | 60614 | — |
| Children's Hospital Boston | Boston | Massachusetts | 02115 | — |
| Washington University & St. Louis Children's Hospital | St Louis | Missouri | 63110 | — |
| Columbia University | New York | New York | 10032 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Hasbro Children's Hospital/Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| University of Utah | Salt Lake City | Utah | 84158 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01365793, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 24, 2018 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01365793 live on ClinicalTrials.gov.