NCT03807648

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2018

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 17, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

January 3, 2019

Last Update Submit

February 10, 2020

Conditions

Kidney Injury

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Rate of hospital admission and readmission

    Within 30 days of initial ED encounter

  • Cost

    Through study completion (an average of 1 year)

Interventions

Data InclusionOTHER

Patients in this group will be included in the project

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84157-7000, United States

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2019

First Posted

January 17, 2019

Study Start

December 20, 2018

Primary Completion

December 31, 2019

Study Completion

January 31, 2020

Last Updated

February 12, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)