SOFI: A Quality Improvement Project to Standardize Use of Intravenous Fluids in Hospitalized Pediatric Patients
Public ClinicalTrials.gov record NCT03924674. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Standardization of Fluids in Inpatient Settings
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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-hypertensive medication, and acute kidney injury (AKI) requiring renal replacement therapy (RRT)/dialysis.
Study identification
- NCT ID
- NCT03924674
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 106 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 28 Days to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2019
- Primary completion
- May 30, 2020
- Completion
- May 30, 2020
- Last update posted
- Apr 28, 2021
2019 – 2020
United States locations
- U.S. sites
- 89
- U.S. states
- 32
- U.S. cities
- 79
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | — |
| Community Regional Medical Center | Fresno | California | 93721 | — |
| Loma Linda University Children's Hospital | Loma Linda | California | 92354 | — |
| Harbor - UCLA Medical Center | Los Angeles | California | 90025 | — |
| UCLA Mattel Children's Hospital | Los Angeles | California | 90095 | — |
| Valley Children's Hospital | Madera | California | 93636 | — |
| Stanford HealthCare-ValleyCare | Pleasanton | California | 94585 | — |
| UCSF Benioff Children's Hospital | San Francisco | California | 94158 | — |
| Valley Presbyterian Hospital | Van Nuys | California | 91405 | — |
| John Muir Medical Center | Walnut Creek | California | 94598 | — |
| Nemours A.I. duPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Wolfson Children's Hosptial | Jacksonville | Florida | 32207 | — |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | — |
| Holtz Children's Hospital | Miami | Florida | 33156 | — |
| Sacred Heart Children's Hospital | Pensacola | Florida | 32504 | — |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | — |
| Johns Hopkins All Childrens Hospital | St. Petersburg | Florida | 33701 | — |
| Advent Health Tampa | Tampa | Florida | 33613 | — |
| Children's Healthcare of Atlanta at Egleston | Atlanta | Georgia | 30322 | — |
| Children's Hospital of Georgia | Augusta | Georgia | 30912 | — |
| Beverly Knight Olson Children's Hospital, Navicent Health | Macon | Georgia | 31201 | — |
| WellStar Kennestone Hospital | Marietta | Georgia | 30060 | — |
| Maui Memorial Medical Center | Wailuku | Hawaii | 96793 | — |
| Saint Alphonsus Medical Center | Boise | Idaho | 83706 | — |
| St. Luke's Children's | Boise | Idaho | 83712 | — |
| Kootenai Health | Coeur d'Alene | Idaho | 83814 | — |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| Rush University Children's Hospital | Chicago | Illinois | 60612 | — |
| University of Illinois Hospital | Chicago | Illinois | 60616 | — |
| Northwestern Lake Forest Hospital | Lake Forest | Illinois | 60045 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Advocate Children's Hospital - Oak Lawn | Oak Lawn | Illinois | 60453 | — |
| Advocate Children's Hospital | Park Ridge | Illinois | 60068 | — |
| OSF Healthcare Children's Hospital of Illinois | Peoria | Illinois | 61637 | — |
| Northwestern Central DuPage Hospital | Winfield | Illinois | 60190 | — |
| Beacon Children's Hospital | South Bend | Indiana | 46601 | — |
| Blank Children's Hospital | Des Moines | Iowa | 50309 | — |
| Stormont Vail Health | Topeka | Kansas | 66604 | — |
| Wesley Medical Center/Wesley Childrens Hospital | Wichita | Kansas | 67214 | — |
| University of Kentucky | Lexington | Kentucky | 40536 | — |
| Our Lady of the Lake Children's Hospital | Baton Rouge | Louisiana | 70808 | — |
| The Barbara Bush Children's Hospital at Maine Medical Center | Portland | Maine | 04102 | — |
| Anne Arundel Medical Center | Annapolis | Maryland | 21401 | — |
| Johns Hopkins Children's Center | Baltimore | Maryland | 21287 | — |
| St. Agnes Hospital | Baltimore | Maryland | 60045 | — |
| Frederick Memorial Hospital | Frederick | Maryland | 21701 | — |
| Peninsula Regional Medical Center | Salisbury | Maryland | 21801 | — |
| Floating Hospital for Children at Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| St. Joseph Mercy Hospital | Ann Arbor | Michigan | 48105 | — |
| C. S. Mott Children's Hospital | Ann Arbor | Michigan | 48109 | — |
| Sparrow Hospital | Lansing | Michigan | 48909 | — |
| Beaumont Children's Hospital | Royal Oak | Michigan | 48073 | — |
| Henry Ford West Bloomfield Hospital | West Bloomfield | Michigan | 48322 | — |
| Children's Minnesota | Minneapolis | Minnesota | 55404 | — |
| University of Mississippi Medical Center Children's Hospital | Jackson | Mississippi | 39216 | — |
| Mercy Children's Hospital-St. Louis | St Louis | Missouri | 63141 | — |
| The Unterberg Children's Hospital | Long Branch | New Jersey | 07740 | — |
| Shore Medical Center | Somers Point | New Jersey | 08244 | — |
| Inspira Medical Center Vineland | Vineland | New Jersey | 08360 | — |
| University of New Mexico Children's Hospital | Albuquerque | New Mexico | 87106 | — |
| Kravis Children's Hospital, The Mount Sinai Hospital | New York | New York | 10029 | — |
| Vassar Brothers Medical Center | Poughkeepsie | New York | 12601 | — |
| Richmond University Medical Center | Staten Island | New York | 10310 | — |
| Maria Fareri Children's Hospital at Westchester Medical Center | Valhalla | New York | 10595 | — |
| Akron Childrens Mahoning Valley | Youngstown | Ohio | 44511 | — |
| Randall Children's Hospital | Portland | Oregon | 97227 | — |
| Doernbecher Children's Hospital | Portland | Oregon | 97235 | — |
| St. Luke's Unversity Health Network | Bethlehem | Pennsylvania | 18015 | — |
| St. Clair Hospital | Mount Lebanon | Pennsylvania | 15243 | — |
| Children's Hospital at Erlanger | Chattanooga | Tennessee | 37403 | — |
| Children's Medical Center Dallas | Dallas | Texas | 75235 | — |
| El Paso Children's Hospital | El Paso | Texas | 79905 | — |
| University of Texas Medical Branch- Galveston | Galveston | Texas | 77555 | — |
| Childrens Memorial Hermann Hospital | Houston | Texas | 77030 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| Covenant Children's Hospital | Lubbock | Texas | 79410 | — |
| Memorial Hermann Community Hospitals | Sugar Land | Texas | 77479 | — |
| University of Virginia Children's Hospital | Charlottesville | Virginia | 22908 | — |
| Augusta Medical Center | Fishersville | Virginia | 22939 | — |
| Mary Washington Hospital | Fredericksburg | Virginia | 22401 | — |
| The Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507 | — |
| Carilion Children's | Roanoke | Virginia | 24014 | — |
| Mary Bridge Children's Hospital | Tacoma | Washington | 98403 | — |
| Central Washington Hospital | Wenatchee | Washington | 98801 | — |
| St. Mary's Hospital | Madison | Wisconsin | 53715 | — |
| American Family Children's Hospital | Madison | Wisconsin | 53794 | — |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
| Children's Hospital of Wisconsin - Fox Valley | Neenah | Wisconsin | 54956 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03924674, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 28, 2021 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03924674 live on ClinicalTrials.gov.