NCT03924674: SOFI

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

Completed NA Last updated 29 April 2021

What this trial tests

NA trial testing Education, clinical decision support tools in Intravenous Fluids in 106 participants. Completed in 31 May 2020.

Timeline

1 April 2019

Primary endpoint
31 May 2020

31 May 2020

Quick facts

Lead sponsor	Seattle Children's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	106
Start date	1 April 2019
Primary completion	31 May 2020
Estimated completion	31 May 2020
Sites	89 locations across United States

Drugs / interventions tested

• Education, clinical decision support tools

Conditions studied

• Intravenous Fluids — all drugs for Intravenous Fluids →
• Fluid and Electrolyte Imbalance — all drugs for Fluid and Electrolyte Imbalance →
• ADH Inappropriate — all drugs for ADH Inappropriate →

Sponsor

Seattle Children's Hospital

Who can join

Adults 28 Days to 18, any sex, with Intravenous Fluids or Fluid and Electrolyte Imbalance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of a Quality Improvement Bundle to Standardize the Use of Intravenous Fluids for Hospitalized Pediatric Patients: A Stepped-Wedge, Cluster Randomized Clinical Trial.
   Rooholamini SN, Jennings B, Zhou C, Kaiser SV, et al · · 2022 · cited 8× · PMID 34779837 · DOI 10.1001/jamapediatrics.2021.4267