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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: Completed Phase 3 study, sponsored by University of California, Davis.
NCT01365793 is a Phase 3 study that has completed, run by University of California, Davis. The registered enrollment target is 1,389 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome is the binary indicator that a patient's GCS score drops below 14 (i.e. abnormal score) within the first 24 hours of treatment of DKA. There will be two treatment factors: sodium concentration of re-hydration fluids and rate of rehydration. These effects will be tested separately, using the Mantel-Haenszel chi-square test, stratified by hospital, and by the other main factor.
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 |
What the finished NCT01365793 record still lists
NCT01365793 is an interventional study that assigns participants to a tested intervention. Its 1,389 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% higher).
The record links to 0 conditions, and to 4 interventions - of which 0.45% saline replacement fluid is the first listed.
NCT01365793 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01365793's enrollment target sits among peer trials
1,389 176th of 2000 higher than 1,825 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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