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NCT03924674 · ClinicalTrials.gov registry record · NA
SOFI: A Quality Improvement Project to Standardize Use of Intravenous Fluids in Hospitalized Pediatric Patients
A NA study of Intravenous Fluids and Fluid and Electrolyte Imbalance, sponsored by Seattle Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 106
- Enrollment target
- 20
- Study locations
NCT03924674: Completed NA study of Intravenous Fluids and Fluid and Electrolyte Imbalance, sponsored by Seattle Children's Hospital.
NCT03924674 is a NA study of Intravenous Fluids and Fluid and Electrolyte Imbalance that has completed, run by Seattle Children's Hospital. The registered enrollment target is 106 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03924674, a NA study of Intravenous Fluids and Fluid and Electrolyte Imbalance, has completed, sponsored by Seattle Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 106 participants
- Enrollment target
- 20
- Study locations
Study Summary
Intravenous fluids (IVF) are used in hospitalized patients to replenish the fluid and electrolyte losses of patients who cannot take adequate hydration by mouth or through their gut. Inappropriate use of IVF may cause serious problems, including abnormalities in blood electrolytes such as sodium, which can lead to serious but rare neurologic harm; pain and discomfort from multiple IV insertions and subsequent complications (e.g., IV infiltration); and inadequate monitoring for adverse effects. Investigators currently don't know what the most commonly used IVF in hospitalized pediatric patients are, and there are no national benchmark data for IVF use. The American Academy of Pediatrics published a Guideline on maintenance IVF in November 2018, which contains one major recommendation: to use isotonic (having a similar electrolyte concentration to blood plasma) maintenance IVF in medical and surgical patients 28 days to 18 years old without pre-existing serious illnesses. This project aims to better describe and standardize the use of IVF in inpatient pediatric settings across the U.S. and evaluate the impact of an intervention bundle on maintenance IVF use. This project aims to improve health care value by reducing the number of routine laboratory draws. In Quality Improvement research, there are three different types of measures - outcome measures, process measures and balancing measures. In this project, the following will be used as a process measure: The proportion of daily weight measurements for patients on maintenance IVF. The following will be used as balancing measures: 1. There will be no increase in the number of floor-to-PICU transfers during hospitalization from baseline. 2. There will be no increase in the number of serum sodium lab results obtained from baseline. 3. There will be no increase in adverse events prompting a change in clinical management from baseline: hypertension or edema requiring a diuretic, hypertension requiring anti-hypertens
Primary Outcome
Increase mean proportion of hours per hospital day with exclusive isotonic IVF use to ≥80% by May 2020.
Conditions Studied
Interventions
- OTHER Education, clinical decision support tools
Study Locations (20)
California
- Community Regional Medical Center - Fresno
- Loma Linda University Children's Hospital - Loma Linda
- Harbor - UCLA Medical Center - Los Angeles
- UCLA Mattel Children's Hospital - Los Angeles
- Valley Children's Hospital - Madera
- Stanford HealthCare-ValleyCare - Pleasanton
- UCSF Benioff Children's Hospital - San Francisco
- Valley Presbyterian Hospital - Van Nuys
- John Muir Medical Center - Walnut Creek
Florida
- Wolfson Children's Hosptial - Jacksonville
- Nicklaus Children's Hospital - Miami
- Holtz Children's Hospital - Miami
- Sacred Heart Children's Hospital - Pensacola
- Sarasota Memorial Hospital - Sarasota
- Johns Hopkins All Childrens Hospital - St. Petersburg
- Advent Health Tampa - Tampa
Arizona
- Phoenix Children's Hospital - Phoenix
Delaware
- Nemours A.I. duPont Hospital for Children - Wilmington
District of Columbia
- Children's National Medical Center - Washington D.C.
Georgia
- Children's Healthcare of Atlanta at Egleston - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2020-05-31 |
| Phase | NA |
What the finished NCT03924674 record still lists
NCT03924674 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 3 conditions, with Intravenous Fluids appearing as the primary indexed condition, and to 1 intervention - of which Education, clinical decision support tools is the first listed.
NCT03924674 names 20 study sites across 6 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT03924674 about?
NCT03924674 is a clinical study titled "SOFI: A Quality Improvement Project to Standardize Use of Intravenous Fluids in Hospitalized Pediatric Patients". Intravenous fluids (IVF) are used in hospitalized patients to replenish the fluid and electrolyte losses of patients who cannot take adequate hydration by mouth or through their gut. Inappropriate use of IVF may cause serious problems, including abnormalities in blood electrolytes such as sodium, wh...
What is the current status of trial NCT03924674?
This trial is currently completed. It is a NA study. The enrollment target is 106 participants. The study started on 2019-04-01. Estimated completion is 2020-05-31.
What conditions does trial NCT03924674 study?
This clinical trial studies the following conditions: Intravenous Fluids, Fluid and Electrolyte Imbalance, ADH Inappropriate.
What interventions are being tested in trial NCT03924674?
The interventions under investigation include: Education, clinical decision support tools (OTHER).
Who is sponsoring clinical trial NCT03924674?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03924674 being conducted?
This trial has 20 study locations across Arizona, California, Delaware, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03924674's enrollment target sits among peer trials
106 830th of 2000 higher than 1,167 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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