An Electronic Alert System for In-Hospital Acute Kidney Injury

Acute Kidney Injury Clinical Trial

Official title:

An Electronic Alert System for In-Hospital Acute Kidney Injury: A Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01862419
• Other study ID #: 817822
• Status: Completed
• Phase: N/A
• First received: May 16, 2013
• Last updated: March 13, 2015
• Start date: September 2013
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study will randomize hospitalized patients with acute kidney injury (AKI) to usual care, or an electronic alert intervention. The electronic alert will be in the form of a text page that will be sent to the covering clinician and unit pharmacist once per patient with AKI at the time lab results are uploaded. The investigators hypothesize that such an alert will improve outcomes in these patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2393
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults >=18 years

• Admitted to the Hospital of the University of Pennsylvania for greater than 24 hours.

Exclusion Criteria:

• Dialysis order within 24 hours of admission

• Dialysis order prior to AKI onset

• Initial creatinine >=4.0mg/dl

• Prior admission in which patient was randomized.

• Nephrectomy during the admission

• Admission to hospice service

• Admission to observation status

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Other:
• Alert

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Phiadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dialysis Within 7 Days	This metric will be sequentially ranked. The provision of acute dialysis therapy will be ranked as a more severe outcome than the worst relative change in creatinine and death will be ranked as a more severe outcome than dialysis.	From start of AKI to 7 days later	No
Primary	Death		7 days of randomization	No
Primary	Relative Maximum Change in Creatinine		7 days of randomization	No