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An Electronic Alert System for In-Hospital Acute Kidney Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01862419
Recruitment Status : Completed
First Posted : May 24, 2013
Results First Posted : March 25, 2015
Last Update Posted : March 25, 2015
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Other: Alert Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2393 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Electronic Alert System for In-Hospital Acute Kidney Injury: A Randomized, Controlled Trial
Study Start Date : September 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

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 Name: 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.



Primary Outcome Measures :
  1. 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.

  2. Death [ Time Frame: 7 days of randomization ]
  3. Relative Maximum Change in Creatinine [ Time Frame: 7 days of randomization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01862419


Locations
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United States, Pennsylvania
Hospital of the University of Pennsylvania
Phiadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Barry Fuchs, MD University of Pennsylvania
Principal Investigator: Francis P Wilson, MD MSCE University of Pennsylvania
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01862419    
Other Study ID Numbers: 817822
First Posted: May 24, 2013    Key Record Dates
Results First Posted: March 25, 2015
Last Update Posted: March 25, 2015
Last Verified: April 2014
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases