FindMyKOL
Clinical trialNCT03924674CompletedInterventional

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

SponsorSeattle Children's HospitalEnrollment106ADH InappropriateFluid and Electrolyte ImbalanceIntravenous Fluids
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

  • Sahar N Rooholamini, MD, MPH

    Seattle Children's Hospital/Univ. of Washington

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

89 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Phoenix Children'S Hospital

    Phoenix, Arizona, United States

  • Community Regional Medical Center

    Fresno, California, United States

  • Loma Linda University Children'S Hospital

    Loma Linda, California, United States

  • Harbor - Ucla Medical Center

    Los Angeles, California, United States

  • Ucla Mattel Children'S Hospital

    Los Angeles, California, United States

  • Valley Children'S Hospital

    Madera, California, United States

  • Stanford Healthcare-Valleycare

    Pleasanton, California, United States

  • Ucsf Benioff Children'S Hospital

    San Francisco, California, United States

  • Valley Presbyterian Hospital

    Van Nuys, California, United States

  • John Muir Medical Center

    Walnut Creek, California, United States

  • Nemours A.I. Dupont Hospital for Children

    Wilmington, Delaware, United States

  • Children'S National Medical Center

    Washington D.C., District of Columbia, United States

  • Wolfson Children'S Hosptial

    Jacksonville, Florida, United States

  • Holtz Children'S Hospital

    Miami, Florida, United States

  • Nicklaus Children'S Hospital

    Miami, Florida, United States

  • Sacred Heart Children'S Hospital

    Pensacola, Florida, United States

  • Sarasota Memorial Hospital

    Sarasota, Florida, United States

  • Johns Hopkins All Childrens Hospital

    St. Petersburg, Florida, United States

  • Advent Health Tampa

    Tampa, Florida, United States

  • Children'S Healthcare of Atlanta at Egleston

    Atlanta, Georgia, United States

  • Children'S Hospital of Georgia

    Augusta, Georgia, United States

  • Beverly Knight Olson Children'S Hospital, Navicent Health

    Macon, Georgia, United States

  • Wellstar Kennestone Hospital

    Marietta, Georgia, United States

  • Maui Memorial Medical Center

    Wailuku, Hawaii, United States

  • Saint Alphonsus Medical Center

    Boise, Idaho, United States

  • St. Luke'S Children'S

    Boise, Idaho, United States

  • Kootenai Health

    Coeur d'Alene, Idaho, United States

  • Ann & Robert H. Lurie Children'S Hospital of Chicago

    Chicago, Illinois, United States

  • Rush University Children'S Hospital

    Chicago, Illinois, United States

  • University of Illinois Hospital

    Chicago, Illinois, United States

  • Northwestern Lake Forest Hospital

    Lake Forest, Illinois, United States

  • Loyola University Medical Center

    Maywood, Illinois, United States

  • Advocate Children'S Hospital - Oak Lawn

    Oak Lawn, Illinois, United States

  • Advocate Children'S Hospital

    Park Ridge, Illinois, United States

  • Osf Healthcare Children'S Hospital of Illinois

    Peoria, Illinois, United States

  • Northwestern Central Dupage Hospital

    Winfield, Illinois, United States

  • Beacon Children'S Hospital

    South Bend, Indiana, United States

  • Blank Children'S Hospital

    Des Moines, Iowa, United States

  • Stormont Vail Health

    Topeka, Kansas, United States

  • Wesley Medical Center/wesley Childrens Hospital

    Wichita, Kansas, United States

49 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
1 Apr 2019
Primary completion
31 May 2020
Completion
31 May 2020
Last update posted
29 Apr 2021
Registered enrollment
106
Registry id
NCT03924674

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.