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NCT03066440 · ClinicalTrials.gov registry record · Phase 4
Double Blinded Randomized Control Trial of Types of IVF in Children With DKA
A Phase 4 study, sponsored by State University of New York at Buffalo.
- Terminated
- Registry status
- Phase 4
- Development phase
- 53
- Enrollment target
NCT03066440: Clinical Trial Phase 4 study, sponsored by State University of New York at Buffalo.
NCT03066440 is a Phase 4 study that was terminated before completion, run by State University of New York at Buffalo. The registered enrollment target is 53 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03066440, a Phase 4 study, was terminated before completion, sponsored by State University of New York at Buffalo.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 53 participants
- Enrollment target
Study Summary
Objectives: Intravenous (IV) fluid administration is a fundamental component of diabetic ketoacidosis (DKA) treatment. Normal saline (NS), the most common IV fluid used in DKA management, contains more chloride than human blood. Excessive amounts of chloride have been shown to cause a detrimental metabolic acidosis. Other IV fluids have more physiologic chloride levels, such as lactated ringers (LR). This study will compare the rates of hyperchloremic metabolic acidosis in children treated with NS to those treated with LR to determine the effect on overall length of acidosis and length of stay in the hospital or intensive care unit. Design: Single-center, double blinded, randomized controlled trial. Subjects: Children aged 0 to 18 years who present with diabetic ketoacidosis and require pediatric intensive care unit admission. Patients with evidence of shock, multi-organ failure or clinically significant cerebral edema will be excluded. The projected study population will be 104 patients, 52 in each arm. Interventions: Patients will be enrolled within 1 hour of presentation to the emergency room or pediatric intensive care unit if transferred directly from another facility. They will be randomized to receive intravenous fluids containing 0.9% saline or lactated ringers. All patients will be treated using the institutional DKA protocol with the content of the intravenous fluids being the only difference in treatment between arms. Study intervention lasts until the end of the acute management of DKA. Planned measurements and study outcomes: The primary study outcome will be duration of metabolic acidosis. Resolution of metabolic acidosis will be defined in three ways: 1. Normalization of the ketosis; 2. Normalization of the serum pH; 3. Normalization of the serum bicarbonate level. Secondary outcomes will include length of stay in the pediatric intensive care unit and length of stay in the hospital. All outcomes will be correlated with the overall chloride load gi
Primary Outcome
Hours to pH\>7.25 and normal anion gap and serum bicarbonate over 15
Interventions
- DRUG Normal saline
- DRUG Lactated Ringers
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2018-09-01 |
| Est. Completion | 2024-03-18 |
| Phase | Phase 4 |
Why NCT03066440 stopped before completion
NCT03066440 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Normal saline is the first listed.
NCT03066440 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03066440 about?
NCT03066440 is a clinical study titled "Double Blinded Randomized Control Trial of Types of IVF in Children With DKA". Objectives: Intravenous (IV) fluid administration is a fundamental component of diabetic ketoacidosis (DKA) treatment. Normal saline (NS), the most common IV fluid used in DKA management, contains more chloride than human blood. Excessive amounts of chloride have been shown to cause a detrimental me...
What is the current status of trial NCT03066440?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 53 participants. The study started on 2018-09-01. Estimated completion is 2024-03-18.
What interventions are being tested in trial NCT03066440?
The interventions under investigation include: Normal saline (DRUG), Lactated Ringers (DRUG).
Who is sponsoring clinical trial NCT03066440?
This trial is sponsored by State University of New York at Buffalo, which has 243 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03066440's enrollment target sits among peer trials
53 1229th of 2000 higher than 768 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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