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

Fluid and Electrolyte Imbalance Clinical Trial

— SOFI  

Official title:

Standardization of Fluids in Inpatient Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03924674
• Other study ID #: AAP VIP Network SOFI study
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: May 31, 2020

Study information

• Verified date: April 2021
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Education, clinical decision support tools
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

Locations

Country	Name	City	State
United States	University of New Mexico Children's Hospital	Albuquerque	New Mexico
United States	C. S. Mott Children's Hospital	Ann Arbor	Michigan
United States	St. Joseph Mercy Hospital	Ann Arbor	Michigan
United States	Anne Arundel Medical Center	Annapolis	Maryland
United States	Children's Healthcare of Atlanta at Egleston	Atlanta	Georgia
United States	Children's Hospital of Georgia	Augusta	Georgia
United States	Johns Hopkins Children's Center	Baltimore	Maryland
United States	St. Agnes Hospital	Baltimore	Maryland
United States	Our Lady of the Lake Children's Hospital	Baton Rouge	Louisiana
United States	St. Luke's Unversity Health Network	Bethlehem	Pennsylvania
United States	Saint Alphonsus Medical Center	Boise	Idaho
United States	St. Luke's Children's	Boise	Idaho
United States	Floating Hospital for Children at Tufts Medical Center	Boston	Massachusetts
United States	University of Virginia Children's Hospital	Charlottesville	Virginia
United States	Children's Hospital at Erlanger	Chattanooga	Tennessee
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Rush University Children's Hospital	Chicago	Illinois
United States	University of Illinois Hospital	Chicago	Illinois
United States	Kootenai Health	Coeur d'Alene	Idaho
United States	Children's Medical Center Dallas	Dallas	Texas
United States	Blank Children's Hospital	Des Moines	Iowa
United States	El Paso Children's Hospital	El Paso	Texas
United States	Augusta Medical Center	Fishersville	Virginia
United States	Frederick Memorial Hospital	Frederick	Maryland
United States	Mary Washington Hospital	Fredericksburg	Virginia
United States	Community Regional Medical Center	Fresno	California
United States	University of Texas Medical Branch- Galveston	Galveston	Texas
United States	Childrens Memorial Hermann Hospital	Houston	Texas
United States	Texas Children's Hospital	Houston	Texas
United States	University of Mississippi Medical Center Children's Hospital	Jackson	Mississippi
United States	Wolfson Children's Hosptial	Jacksonville	Florida
United States	Northwestern Lake Forest Hospital	Lake Forest	Illinois
United States	Sparrow Hospital	Lansing	Michigan
United States	University of Kentucky	Lexington	Kentucky
United States	Loma Linda University Children's Hospital	Loma Linda	California
United States	The Unterberg Children's Hospital	Long Branch	New Jersey
United States	Harbor - UCLA Medical Center	Los Angeles	California
United States	UCLA Mattel Children's Hospital	Los Angeles	California
United States	Covenant Children's Hospital	Lubbock	Texas
United States	Beverly Knight Olson Children's Hospital, Navicent Health	Macon	Georgia
United States	Valley Children's Hospital	Madera	California
United States	American Family Children's Hospital	Madison	Wisconsin
United States	St. Mary's Hospital	Madison	Wisconsin
United States	WellStar Kennestone Hospital	Marietta	Georgia
United States	Loyola University Medical Center	Maywood	Illinois
United States	Holtz Children's Hospital	Miami	Florida
United States	Nicklaus Children's Hospital	Miami	Florida
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin
United States	Children's Minnesota	Minneapolis	Minnesota
United States	St. Clair Hospital	Mount Lebanon	Pennsylvania
United States	Children's Hospital of Wisconsin - Fox Valley	Neenah	Wisconsin
United States	Kravis Children's Hospital, The Mount Sinai Hospital	New York	New York
United States	The Children's Hospital of The King's Daughters	Norfolk	Virginia
United States	Advocate Children's Hospital - Oak Lawn	Oak Lawn	Illinois
United States	Advocate Children's Hospital	Park Ridge	Illinois
United States	Sacred Heart Children's Hospital	Pensacola	Florida
United States	OSF Healthcare Children's Hospital of Illinois	Peoria	Illinois
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	Stanford HealthCare-ValleyCare	Pleasanton	California
United States	Doernbecher Children's Hospital	Portland	Oregon
United States	Randall Children's Hospital	Portland	Oregon
United States	The Barbara Bush Children's Hospital at Maine Medical Center	Portland	Maine
United States	Vassar Brothers Medical Center	Poughkeepsie	New York
United States	Carilion Children's	Roanoke	Virginia
United States	Beaumont Children's Hospital	Royal Oak	Michigan
United States	Mercy Children's Hospital-St. Louis	Saint Louis	Missouri
United States	Johns Hopkins All Childrens Hospital	Saint Petersburg	Florida
United States	Peninsula Regional Medical Center	Salisbury	Maryland
United States	UCSF Benioff Children's Hospital	San Francisco	California
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Shore Medical Center	Somers Point	New Jersey
United States	Beacon Children's Hospital	South Bend	Indiana
United States	Richmond University Medical Center	Staten Island	New York
United States	Memorial Hermann Community Hospitals	Sugar Land	Texas
United States	Mary Bridge Children's Hospital	Tacoma	Washington
United States	Advent Health Tampa	Tampa	Florida
United States	Stormont Vail Health	Topeka	Kansas
United States	Maria Fareri Children's Hospital at Westchester Medical Center	Valhalla	New York
United States	Valley Presbyterian Hospital	Van Nuys	California
United States	Inspira Medical Center Vineland	Vineland	New Jersey
United States	Maui Memorial Medical Center	Wailuku	Hawaii
United States	John Muir Medical Center	Walnut Creek	California
United States	Children's National Medical Center	Washington	District of Columbia
United States	Central Washington Hospital	Wenatchee	Washington
United States	Henry Ford West Bloomfield Hospital	West Bloomfield	Michigan
United States	Wesley Medical Center/Wesley Childrens Hospital	Wichita	Kansas
United States	Nemours A.I. duPont Hospital for Children	Wilmington	Delaware
United States	Northwestern Central DuPage Hospital	Winfield	Illinois
United States	Akron Childrens Mahoning Valley	Youngstown	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	American Academy of Pediatrics

Country where clinical trial is conducted

United States, 

References & Publications (2)

Feld LG, Neuspiel DR, Foster BA, Leu MG, Garber MD, Austin K, Basu RK, Conway EE Jr, Fehr JJ, Hawkins C, Kaplan RL, Rowe EV, Waseem M, Moritz ML; SUBCOMMITTEE ON FLUID AND ELECTROLYTE THERAPY. Clinical Practice Guideline: Maintenance Intravenous Fluids in Children. Pediatrics. 2018 Dec;142(6). pii: e20183083. doi: 10.1542/peds.2018-3083. Review. — View Citation

Rooholamini SN, Clifton H, Haaland W, McGrath C, Vora SB, Crowell CS, Romero H, Foti J. Outcomes of a Clinical Pathway to Standardize Use of Maintenance Intravenous Fluids. Hosp Pediatr. 2017 Dec;7(12):703-709. doi: 10.1542/hpeds.2017-0099. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluid Tonicity	Increase mean proportion of hours per hospital day with exclusive isotonic IVF use to =80% by May 2020.	Monthly reports will be generated each month for each participating site through study completion, approximately 9 months.
Primary	Routine Labs	Decrease number of serum WBC levels (proxy for routine labs) per hospital day by 20% from baseline by May 2020.	Monthly reports will be generated each month for each participating site through study completion, approximately 9 months.
Secondary	IVF duration	Decrease proportion of time (hours) on maintenance IVF during hospitalization by 10% from baseline by May 2020.	Monthly reports will be generated each month for each participating site through study completion, approximately 9 months.