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

Fluid and Electrolyte Imbalance Clinical Trial

Official title: Standardization of Fluids in Inpatient Settings

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

Study Design

All sites will participate in a stepped wedge cluster randomized trial, with 80-120 sites total. This design is helpful when simultaneous implementation of an intervention is not feasible or practical, and allows for each site to collect baseline data for comparison with post-intervention data. There will be 3 groups (or clusters) of approximately 30-40 sites each, with randomization to intervention occurring at 2 month intervals. Randomization will be stratified by: geographic region, size and baseline rate of IVF use. ;

Related Conditions & MeSH terms

• ADH Inappropriate
• Fluid and Electrolyte Imbalance
• Inappropriate ADH Syndrome
• Intravenous Fluids

• NCT number: NCT03924674
• Study type: Interventional
• Source: Seattle Children's Hospital
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Completion date: May 31, 2020