Intravenous FluidsSOFINCT03924674
SOFI: A Quality Improvement Project to Standardize Use of Intravenous Fluids in Hospitalized Pediatric Patients
A study testing Education, clinical decision support tools in people with Intravenous Fluids and Fluid and Electrolyte Imbalance, run by Seattle Children's Hospital at 89 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 28 days to 18 years
- Conditions the study is for
- Intravenous Fluids, Fluid and Electrolyte Imbalance, ADH Inappropriate
- What is being tested?
- Education, clinical decision support tools
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 89 sitesUnited States
- Study dates
- 1 Apr 2019to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
89 sites in 1 country.
89 sites in 1 country
United States89 sites
University of New Mexico Children's Hospital
Albuquerque, New Mexico, 87106
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48105
C. S. Mott Children's Hospital
Ann Arbor, Michigan, 48109
Anne Arundel Medical Center
Annapolis, Maryland, 21401
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322
Children's Hospital of Georgia
Augusta, Georgia, 30912
Johns Hopkins Children's Center
Baltimore, Maryland, 21287
St. Agnes Hospital
Baltimore, Maryland, 60045
Our Lady of the Lake Children's Hospital
Baton Rouge, Louisiana, 70808
St. Luke's Unversity Health Network
Bethlehem, Pennsylvania, 18015
Saint Alphonsus Medical Center
Boise, Idaho, 83706
St. Luke's Children's
Boise, Idaho, 83712
Floating Hospital for Children at Tufts Medical Center
Boston, Massachusetts, 02111
University of Virginia Children's Hospital
Charlottesville, Virginia, 22908
Children's Hospital at Erlanger
Chattanooga, Tennessee, 37403
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Rush University Children's Hospital
Chicago, Illinois, 60612
University of Illinois Hospital
Chicago, Illinois, 60616
Kootenai Health
Coeur d'Alene, Idaho, 83814
Children's Medical Center Dallas
Dallas, Texas, 75235
Blank Children's Hospital
Des Moines, Iowa, 50309
El Paso Children's Hospital
El Paso, Texas, 79905
Augusta Medical Center
Fishersville, Virginia, 22939
Frederick Memorial Hospital
Frederick, Maryland, 21701
Mary Washington Hospital
Fredericksburg, Virginia, 22401
Community Regional Medical Center
Fresno, California, 93721
University of Texas Medical Branch- Galveston
Galveston, Texas, 77555
Childrens Memorial Hermann Hospital
Houston, Texas, 77030
Texas Children's Hospital
Houston, Texas, 77030
University of Mississippi Medical Center Children's Hospital
Jackson, Mississippi, 39216
Wolfson Children's Hosptial
Jacksonville, Florida, 32207
Northwestern Lake Forest Hospital
Lake Forest, Illinois, 60045
Sparrow Hospital
Lansing, Michigan, 48909
University of Kentucky
Lexington, Kentucky, 40536
Loma Linda University Children's Hospital
Loma Linda, California, 92354
The Unterberg Children's Hospital
Long Branch, New Jersey, 07740
Harbor - UCLA Medical Center
Los Angeles, California, 90025
UCLA Mattel Children's Hospital
Los Angeles, California, 90095
Covenant Children's Hospital
Lubbock, Texas, 79410
Beverly Knight Olson Children's Hospital, Navicent Health
Macon, Georgia, 31201
Valley Children's Hospital
Madera, California, 93636
St. Mary's Hospital
Madison, Wisconsin, 53715
American Family Children's Hospital
Madison, Wisconsin, 53794
WellStar Kennestone Hospital
Marietta, Georgia, 30060
Loyola University Medical Center
Maywood, Illinois, 60153
Nicklaus Children's Hospital
Miami, Florida, 33155
Holtz Children's Hospital
Miami, Florida, 33156
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Children's Minnesota
Minneapolis, Minnesota, 55404
St. Clair Hospital
Mount Lebanon, Pennsylvania, 15243
Children's Hospital of Wisconsin - Fox Valley
Neenah, Wisconsin, 54956
Kravis Children's Hospital, The Mount Sinai Hospital
New York, New York, 10029
The Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507
Advocate Children's Hospital - Oak Lawn
Oak Lawn, Illinois, 60453
Advocate Children's Hospital
Park Ridge, Illinois, 60068
Sacred Heart Children's Hospital
Pensacola, Florida, 32504
OSF Healthcare Children's Hospital of Illinois
Peoria, Illinois, 61637
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Stanford HealthCare-ValleyCare
Pleasanton, California, 94585
The Barbara Bush Children's Hospital at Maine Medical Center
Portland, Maine, 04102
Randall Children's Hospital
Portland, Oregon, 97227
Doernbecher Children's Hospital
Portland, Oregon, 97235
Vassar Brothers Medical Center
Poughkeepsie, New York, 12601
Carilion Children's
Roanoke, Virginia, 24014
Beaumont Children's Hospital
Royal Oak, Michigan, 48073
Peninsula Regional Medical Center
Salisbury, Maryland, 21801
UCSF Benioff Children's Hospital
San Francisco, California, 94158
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Shore Medical Center
Somers Point, New Jersey, 08244
Beacon Children's Hospital
South Bend, Indiana, 46601
Mercy Children's Hospital-St. Louis
St Louis, Missouri, 63141
Johns Hopkins All Childrens Hospital
St. Petersburg, Florida, 33701
Richmond University Medical Center
Staten Island, New York, 10310
Memorial Hermann Community Hospitals
Sugar Land, Texas, 77479
Mary Bridge Children's Hospital
Tacoma, Washington, 98403
Advent Health Tampa
Tampa, Florida, 33613
Stormont Vail Health
Topeka, Kansas, 66604
Maria Fareri Children's Hospital at Westchester Medical Center
Valhalla, New York, 10595
Valley Presbyterian Hospital
Van Nuys, California, 91405
Inspira Medical Center Vineland
Vineland, New Jersey, 08360
Maui Memorial Medical Center
Wailuku, Hawaii, 96793
John Muir Medical Center
Walnut Creek, California, 94598
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Central Washington Hospital
Wenatchee, Washington, 98801
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322
Wesley Medical Center/Wesley Childrens Hospital
Wichita, Kansas, 67214
Nemours A.I. duPont Hospital for Children
Wilmington, Delaware, 19803
Northwestern Central DuPage Hospital
Winfield, Illinois, 60190
Akron Childrens Mahoning Valley
Youngstown, Ohio, 44511
About this study
Official title: Standardization of Fluids in Inpatient Settings
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.
Read more
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:
- There will be no increase in the number of floor-to-PICU transfers during hospitalization from baseline.
- There will be no increase in the number of serum sodium lab results obtained from baseline.
- 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.
Read the detailed 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.
- Being tested
- Education, clinical decision support tools
- Medical subject headings
- Inappropriate ADH Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education, clinical decision support toolsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Stepped Wedge Group 1: Sept. 2019 Launch | Active comparator | 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 Receives: Other: Education, clinical decision support tools |
| Stepped Wedge Group 2: Nov. 2019 Launch | Active comparator | 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 Receives: Other: Education, clinical decision support tools |
| Stepped Wedge Group 3: Jan. 2020 Launch | Active comparator | 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 Receives: Other: Education, clinical decision support tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid Tonicity
Increase mean proportion of hours per hospital day with exclusive isotonic IVF use to ≥80% by May 2020.
Measured: Monthly reports will be generated each month for each participating site through study completion, approximately 9 months.
Routine Labs
Decrease number of serum WBC levels (proxy for routine labs) per hospital day by 20% from baseline by May 2020.
Measured: Monthly reports will be generated each month for each participating site through study completion, approximately 9 months.
Secondary outcomes (1)
IVF duration
Decrease proportion of time (hours) on maintenance IVF during hospitalization by 10% from baseline by May 2020.
Measured: Monthly reports will be generated each month for each participating site through study completion, approximately 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start1 Apr 2019
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intravenous FluidsStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All sites will participate in a stepped wedge cluster randomized trial. 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. By the end of the project, all sites in all groups will have received the intervention toolkit.
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Pediatrics
- Responsible party
- Principal investigator, Sahar Rooholamini, Seattle Children's Hospital
- Investigators
- Sahar N Rooholamini, MD, MPH, Principal investigator, Seattle Children's Hospital/Univ. of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924674
- Sponsor's protocol ID
- AAP VIP Network SOFI study
- Acronym
- SOFI
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2019
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All project data will be analyzed by the study team at the aggregate level and site-level data will not be made available to other researchers.
Publications
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):e20183083. doi: 10.1542/peds.2018-3083.
PubMed 30478247Rooholamini 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.
PubMed 29162640Rooholamini SN, Jennings B, Zhou C, Kaiser SV, Garber MD, Tchou MJ, Ralston SL. Effect of a Quality Improvement Bundle to Standardize the Use of Intravenous Fluids for Hospitalized Pediatric Patients: A Stepped-Wedge, Cluster Randomized Clinical Trial. JAMA Pediatr. 2022 Jan 1;176(1):26-33. doi: 10.1001/jamapediatrics.2021.4267.
PubMed 34779837
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardization of Fluids in Inpatient Settings
- ClinicalTrials.gov ID
- NCT03924674
- Acronym / sponsor ID
- SOFI / AAP VIP Network SOFI study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- American Academy of Pediatrics
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 23 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- There will be no increase in the number of floor-to-PICU transfers during hospitalization from baseline.
- There will be no increase in the number of serum sodium lab results obtained from baseline.
- 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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All sites will participate in a stepped wedge cluster randomized trial. 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. By the end of the project, all sites in all groups will have received the intervention toolkit.
| Arm | Type | Receives |
|---|---|---|
| Stepped Wedge Group 1: Sept. 2019 Launch | Active comparator | Other: Education, clinical decision support toolsInterventions 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 |
| Stepped Wedge Group 2: Nov. 2019 Launch | Active comparator | Other: Education, clinical decision support toolsInterventions 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 |
| Stepped Wedge Group 3: Jan. 2020 Launch | Active comparator | Other: Education, clinical decision support toolsInterventions 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 |
Who may qualify
- Ages
- 28 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education, clinical decision support toolsInterventions 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 | Other | Stepped Wedge Group 1: Sept. 2019 Launch, Stepped Wedge Group 2: Nov. 2019 Launch, Stepped Wedge Group 3: Jan. 2020 Launch |
Primary outcome
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.
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.
1 secondary outcome
IVF duration
Time frame: Monthly reports will be generated each month for each participating site through study completion, approximately 9 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Background: PubMed 30478247Feld 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):e20183083. doi: 10.1542/peds.2018-3083.
- Background: PubMed 29162640Rooholamini 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.
- Derived from this study: PubMed 34779837Rooholamini SN, Jennings B, Zhou C, Kaiser SV, Garber MD, Tchou MJ, Ralston SL. Effect of a Quality Improvement Bundle to Standardize the Use of Intravenous Fluids for Hospitalized Pediatric Patients: A Stepped-Wedge, Cluster Randomized Clinical Trial. JAMA Pediatr. 2022 Jan 1;176(1):26-33. doi: 10.1001/jamapediatrics.2021.4267.
- Individual participant dataSharing planned: No. All project data will be analyzed by the study team at the aggregate level and site-level data will not be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sahar N Rooholamini, MD, MPH principal investigator
Seattle Children's Hospital/Univ. of Washington
89 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education, clinical decision support tools in people with Intravenous Fluids and Fluid and Electrolyte Imbalance, run by Seattle Children's Hospital at 89 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 89 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid Tonicity (time frame: Monthly reports will be generated each month for each participating site through study completion, approximately 9 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03924674, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.