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Completed Not applicable Interventional

SOFI: A Quality Improvement Project to Standardize Use of Intravenous Fluids in Hospitalized Pediatric Patients

ClinicalTrials.gov ID: NCT03924674

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.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 6:59 AM EDT

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
Apr 1, 2019 (Actual)
Primary completion
May 31, 2020 (Actual)
Completion
May 31, 2020 (Actual)
Last update posted
Apr 29, 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 29, 2021 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03924674 live on ClinicalTrials.gov.

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