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Completed

NCT Number: NCT03924674

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

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.

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Key information

Conditions

Intravenous Fluids ADH Inappropriate Brain Diseases Central Nervous System Diseases Endocrine System Diseases Fluid and Electrolyte Imbalance Hypothalamic Diseases Inappropriate ADH Syndrome Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pituitary Diseases Water-Electrolyte Imbalance

Age range

28 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Phoenix Children's Hospital, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Education, clinical decision support tools

Other

Interventions will include:

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

Primary outcomes

  1. Fluid Tonicity

    Time frame: Monthly reports will be generated each month for each participating site through study completion, approximately 9 months.

    Increase mean proportion of hours per hospital day with exclusive isotonic IVF use to ≥80% by May 2020.

  2. Routine Labs

    Time frame: Monthly reports will be generated each month for each participating site through study completion, approximately 9 months.

    Decrease number of serum WBC levels (proxy for routine labs) per hospital day by 20% from baseline by May 2020.

Secondary outcomes

  1. IVF duration

    Time frame: Monthly reports will be generated each month for each participating site through study completion, approximately 9 months.

    Decrease proportion of time (hours) on maintenance IVF during hospitalization by 10% from baseline by May 2020.

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

  • American Academy of Pediatrics

Registry information

Official study title

Standardization of Fluids in Inpatient Settings

Acronym: SOFI

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 23, 2019
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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