Kidney InjuryNCT03807648
I USE LR in the ED
An observational study of Kidney Injury, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
To study the difference in mortality and major adverse kidney events during and after treatment in the emergency department with intravenous fluids per standard of care at 30 days before and after the system-wide implementation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Injury
- What is being tested?
- Data Inclusion
- How many people
- 200,000 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2018to 31 Jan 2020
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Data to determine study outcomes will be extracted from the EDW and stored in a secure database. No actualy contact with patients will take place for this data-only study
Who may be able to join
- Adult patients (≥18 years) receiving a minimum of 1000ml of intravenous fluids starting in the emergency department per standard of care
Who cannot join
- Patients aged ≤17 years
- Previously enrolled patients with >1 ED admission within the 30-day follow-up period
Trial locations and contacts
1 site in 1 country.
United States1 site
Intermountain Medical Center
Murray, Utah, 84157-7000
About this study
Official title: Intermountain Utah Study Evaluating the Implementation of Lactated Ringers as Standard Resuscitation Fluid Starting in Emergency Department
To study the difference in mortality and major adverse kidney events during and after treatment in the emergency department with intravenous fluids per standard of care at 30 days before and after the system-wide implementation.
- Conditions
- Kidney Injury
- Being tested
- Data Inclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data InclusionOther
Patients in this group will be included in the project
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with major Adverse Kidney Events
death from any cause, new renal replacement therapy or persistent renal dysfunction
Measured: within 30 days or at hospital discharge
LR IV Fluids administered
Proportion of LR IV fluids following implementation
Measured: Through study completion (an average of 1 year)
Secondary outcomes (2)
Rate of hospital admission and readmission
Measured: Within 30 days of initial ED encounter
Cost
Direct costs of ED care and hospitalization
Measured: Through study completion (an average of 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start20 Dec 2018
- Primary completion31 Dec 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney InjuryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807648
- Sponsor's protocol ID
- 1050984
- Status last verified
- Feb 2020
- First submitted
- 3 Jan 2019
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermountain Utah Study Evaluating the Implementation of Lactated Ringers as Standard Resuscitation Fluid Starting in Emergency Department
- ClinicalTrials.gov ID
- NCT03807648
- Acronym / sponsor ID
- 1050984
- Conditions
- Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200,000 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 17 Jan 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.
To study the difference in mortality and major adverse kidney events during and after treatment in the emergency department with intravenous fluids per standard of care at 30 days before and after the system-wide implementation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Data to determine study outcomes will be extracted from the EDW and stored in a secure database. No actualy contact with patients will take place for this data-only study
Key inclusion criteria (1 listed)
- Adult patients (≥18 years) receiving a minimum of 1000ml of intravenous fluids starting in the emergency department per standard of care
Key exclusion criteria (2 listed)
- Patients aged ≤17 years
- Previously enrolled patients with >1 ED admission within the 30-day follow-up period
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 |
|---|---|---|
| Data InclusionPatients in this group will be included in the project | Other | – |
Primary outcome
Number of participants with major Adverse Kidney Events
Time frame: within 30 days or at hospital discharge
death from any cause, new renal replacement therapy or persistent renal dysfunction
LR IV Fluids administered
Time frame: Through study completion (an average of 1 year)
Proportion of LR IV fluids following implementation
2 secondary outcomes
Rate of hospital admission and readmission
Time frame: Within 30 days of initial ED encounter
Cost
Time frame: Through study completion (an average of 1 year)
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 12 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Kidney Injury
Enrolling by invitationObservational study
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
Acute Kidney Injury, Fluid Overload
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Postoperative Acute Kidney Injury
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LoW Dose-Intensity vs. Standard Dose-Intensity COntinuous Renal ReplaceMent Therapy in Critically Ill Patients (WISDOM)
Acute Kidney Injury, Dialysis; Complications
Not yet recruiting
Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
Acute Kidney Injury Due to Sepsis
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Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Injury, run by Intermountain Health Care, Inc. at 1 site 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 1 inclusion and 2 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 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of participants with major Adverse Kidney Events (time frame: within 30 days or at hospital discharge). 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?
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 12 Feb 2020.