I USE LR in the ED

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.

Study Overview

• Status: Completed
• Conditions: Kidney Injury
• Intervention / Treatment: Other: Data Inclusion

• Study Type: Observational
• Enrollment (Actual): 200000

Contacts and Locations

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84157-7000
      • Intermountain Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

• Adult patients (≥18 years) receiving a minimum of 1000ml of intravenous fluids starting in the emergency department per standard of care

Exclusion Criteria:

• Patients aged ≤17 years
• Previously enrolled patients with >1 ED admission within the 30-day follow-up period

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with major Adverse Kidney Events	death from any cause, new renal replacement therapy or persistent renal dysfunction	within 30 days or at hospital discharge
LR IV Fluids administered	Proportion of LR IV fluids following implementation	Through study completion (an average of 1 year)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of hospital admission and readmission		Within 30 days of initial ED encounter
Cost	Direct costs of ED care and hospitalization	Through study completion (an average of 1 year)

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: January 3, 2019
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 17, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 1050984

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No