Fluid and Electrolyte Imbalance Clinical Trial
— SOFIOfficial title:
Standardization of Fluids in Inpatient Settings
Verified date | April 2021 |
Source | Seattle Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Seattle Children's Hospital | American Academy of Pediatrics |
United States,
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
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. |
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