An Electronic Alert System for In-Hospital Acute Kidney Injury

March 13, 2015 updated by: University of Pennsylvania

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2393

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Phiadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alert
Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
Other: Alert
Other Names:
  • Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
No Intervention: Usual Care
Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dialysis Within 7 Days
Time Frame: From start of AKI to 7 days later
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
Death
Time Frame: 7 days of randomization
7 days of randomization
Relative Maximum Change in Creatinine
Time Frame: 7 days of randomization
7 days of randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Barry Fuchs, MD, University of Pennsylvania
  • Principal Investigator: Francis P Wilson, MD MSCE, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

May 16, 2013

First Submitted That Met QC Criteria

May 21, 2013

First Posted (Estimate)

May 24, 2013

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 13, 2015

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 817822

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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