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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03807648
Other study ID # 1050984
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 20, 2018
Est. completion date January 31, 2020

Study information

Verified date February 2020
Source Intermountain Health Care, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 200000
Est. completion date January 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Data Inclusion
Patients in this group will be included in the project

Locations

Country Name City State
United States Intermountain Medical Center Murray Utah

Sponsors (1)

Lead Sponsor Collaborator
Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary LR IV Fluids administered Proportion of LR IV fluids following implementation Through study completion (an average of 1 year)
Secondary Rate of hospital admission and readmission Within 30 days of initial ED encounter
Secondary Cost Direct costs of ED care and hospitalization Through study completion (an average of 1 year)
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