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NCT01365793 · ClinicalTrials.gov registry record · Phase 3
Randomized Control Trial of Fluid Therapy for Pediatric Diabetic Ketoacidosis
A Phase 3 study, sponsored by University of California, Davis.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,389
- Enrollment target
NCT01365793 is a Phase 3 study that has completed, run by University of California, Davis. The registered enrollment target is 1,389 participants.
The verdict
NCT01365793, a Phase 3 study, has completed, sponsored by University of California, Davis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,389 participants
- Enrollment target
Study 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.
Interventions
- DRUG 0.45% saline replacement fluid
- DRUG 0.9% saline replacement fluid
- DRUG 0.45% saline intravenous fluid
- DRUG 0.9% saline Intravenous fluid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,389 participants |
| Start Date | 2010-11 |
| Est. Completion | 2017-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01365793
The ClinicalTrials.gov registry entry for NCT01365793 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,389 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Davis, which has 657 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which 0.45% saline replacement fluid is the first listed.
NCT01365793 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01365793 about?
NCT01365793 is a clinical study titled "Randomized Control Trial of Fluid Therapy for Pediatric Diabetic Ketoacidosis". 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 proto...
What is the current status of trial NCT01365793?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,389 participants. The study started on 2010-11. Estimated completion is 2017-01.
What interventions are being tested in trial NCT01365793?
The interventions under investigation include: 0.45% saline replacement fluid (DRUG), 0.9% saline replacement fluid (DRUG), 0.45% saline intravenous fluid (DRUG), 0.9% saline Intravenous fluid (DRUG).
Who is sponsoring clinical trial NCT01365793?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
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