An Electronic Alert System for In-Hospital Acute Kidney Injury

NCT ID: NCT01862419

Last Updated: 2015-03-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2393 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Alert

Intervention Type OTHER

Usual Care

Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Alert

Intervention Type OTHER

Other Intervention Names

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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.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barry Fuchs, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Francis P Wilson, MD MSCE

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Hospital of the University of Pennsylvania

Phiadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25726515 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25023200 (View on PubMed)

Other Identifiers

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817822

Identifier Type: -

Identifier Source: org_study_id

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