CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 106 enrolled
Drug / intervention
Education, clinical decision support toolsother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03924674
NCT03924674N/ACompleted

Standardization of Fluids in Inpatient Settings

Seattle Children's Hospital·interventional·Posted Apr 23, 2019·Updated Apr 29, 2021

In Brief

A clinical study evaluating Education, clinical decision support tools for Intravenous Fluids and 2 related conditions. Completed, enrolled 106 participants across 89 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedApr 23, 2019
Enrollment StartApr 1, 2019
Primary CompletionMay 31, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.2 years ago

Interventions

Education, clinical decision support toolsother

Interventions will include: 1. Education (webinars) for physicians and nurses regarding AAP IVF guidelines, including evidence on safety of isotonic maintenance IVF 2. Implementation of algorithms, ordersets and checklists to guide choice of IVF and clinical indications to start/stop IVF; 3. Tools to promote discussion about timing and necessity of routine lab draws 4. Education and feedback for physicians regarding costs and harms of routine lab testing