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

Completed · Not applicable

Conditions studied: Intravenous Fluids, Fluid and Electrolyte Imbalance, ADH Inappropriate

In brief

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.

Key facts

Study ID

NCT03924674

Run by

Seattle Children's Hospital

People needed

106

Starts

2019-04-01

Expected to finish

2020-05-31

Last updated by the study team

2021-04-29

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥28 days and ≤18 years old at the time of admission
• Received maintenance IVF (rate greater than 10 ml/h) on hospital day #2 at 12:01 am

You may not qualify if…

• ICU (PICU, NICU, CICU, etc.) patients
• Patients who have never gone home from the hospital
• Patients with active adrenal, cardiac, hepatic, neurosurgical, chronic renal, heme/onc, biochemical genetic/metabolic illnesses* (*As evidenced by: (1) listing of a condition in these categories in past medical history; and/or (2) active medication related to one of these conditions)
• Patients with diabetes insipidus, DKA, severe burns
• Patients on a psychiatric hold/primary behavioral health reason for admission with no needed medical management
• Patients with voluminous watery diarrhea > 7 days

Where it is running

• 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
• Nicklaus Children's Hospital — Miami, Florida, United States
• Holtz 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
• Phoenix Children's Hospital — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.