Back to resultsAn Electronic Alert System for In-Hospital Acute Kidney Injury
Primary Purpose
Acute Kidney Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alert
Sponsored by
About this trial
This is an interventional treatment trial for Acute Kidney Injury
Eligibility Criteria
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
Sites / Locations
- Hospital of the University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Alert
Usual Care
Arm Description
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.
Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
Outcomes
Primary Outcome Measures
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.
Death
Relative Maximum Change in Creatinine
Secondary Outcome Measures
Full Information
NCT ID
NCT01862419
First Posted
May 16, 2013
Last Updated
March 13, 2015
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT01862419
Brief Title
An Electronic Alert System for In-Hospital Acute Kidney Injury
Official Title
An Electronic Alert System for In-Hospital Acute Kidney Injury: A Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2393 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alert
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
Intervention Type
Other
Intervention Name(s)
Alert
Other Intervention Name(s)
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.
Primary Outcome Measure Information:
Title
Dialysis Within 7 Days
Description
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.
Time Frame
From start of AKI to 7 days later
Title
Death
Time Frame
7 days of randomization
Title
Relative Maximum Change in Creatinine
Time Frame
7 days of randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry Fuchs, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francis P Wilson, MD MSCE
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Phiadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25726515
Citation
Wilson FP, Shashaty M, Testani J, Aqeel I, Borovskiy Y, Ellenberg SS, Feldman HI, Fernandez H, Gitelman Y, Lin J, Negoianu D, Parikh CR, Reese PP, Urbani R, Fuchs B. Automated, electronic alerts for acute kidney injury: a single-blind, parallel-group, randomised controlled trial. Lancet. 2015 May 16;385(9981):1966-74. doi: 10.1016/S0140-6736(15)60266-5. Epub 2015 Feb 26.
Results Reference
derived
PubMed Identifier
25023200
Citation
Wilson FP, Reese PP, Shashaty MG, Ellenberg SS, Gitelman Y, Bansal AD, Urbani R, Feldman HI, Fuchs B. A trial of in-hospital, electronic alerts for acute kidney injury: design and rationale. Clin Trials. 2014 Oct;11(5):521-9. doi: 10.1177/1740774514542619. Epub 2014 Jul 14.
Results Reference
derived
Learn more about this trial
An Electronic Alert System for In-Hospital Acute Kidney Injury
We'll reach out to this number within 24 hrs