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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 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.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03066440
The ClinicalTrials.gov registry entry for NCT03066440 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is State University of New York at Buffalo, which has 243 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Normal saline is the first listed.
NCT03066440 reports 0 study locations.
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.
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