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Learning Alerts for 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02786277
Recruitment Status : Not yet recruiting
First Posted : May 30, 2016
Last Update Posted : May 21, 2020
Information provided by (Responsible Party):
Yale University

Brief Summary:
In this trial, individuals with Acute Kidney Injury will be randomized to usual care or to an electronic AKI alert system. In three phases, the alert system will be trained to identify those most likely to benefit from the alert, and inclusion criteria will be modified.

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

Detailed Description:

Acute kidney injury (AKI) carries a significant, independent risk of mortality among hospitalized patients. Recent studies have demonstrated increased mortality among patients with even small increases in serum creatinine concentration. International guidelines for the treatment of AKI focus on appropriate management of drug dosing, avoiding nephrotoxic exposures, and careful attention to fluid and electrolyte balance. Early nephrologist involvement may also improve outcomes in AKI. Without appropriate provider recognition of AKI, however, none of these measures can be taken, and patient outcomes may suffer. AKI is frequently overlooked by clinicians, but carries a substantial cost, morbidity and mortality burden.

The investigators conducted a pilot, randomized trial of electronic alerts for acute kidney injury in 2014. The trial, which randomized 2400 patients with AKI as defined by an increase in creatinine of 0.3mg/dl over 48 hours or 50% over 7 days, found that alerting physicians to the presence of AKI did not improve the course of acute kidney injury, reduce dialysis or death rates. However this study was conducted in a single hospital, and the alert itself did not describe specific actions that a provider could take. In the present proposal, the investigators seek to expand upon their prior study to determine both the modes of alerting that would be most effective and to determine if targeting alerts (such as to patients on medications that may worsen acute kidney injury) will improve effectiveness.

This study will be a randomized, controlled trial of an electronic AKI alert system. Using the Kidney Disease: Improve Global Outcomes creatinine criteria, inpatients at several hospitals will be randomized to usual care versus electronic alerting. Over three separate study intervals, uplift models will be created to identify clusters of patients expected to benefit most from alerting, and randomization will be tailored to that group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Uplift Modeling to More Narrowly Target Alerts for Acute Kidney Injury
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
No Intervention: Usual Care
No alert will be fired
Experimental: Alert
An alert informing the provider of acute kidney injury will be fired.
Other: Alert
An alert informing the provider of the presence of acute kidney injury will be fired.

Primary Outcome Measures :
  1. Proportion of patients with progression to a higher stage of AKI OR Dialysis OR Death [ Time Frame: 14 days from randomization ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Phase 1 of the trial will enroll all inpatients at study hospitals who meet Kidney Disease: Improving Global Outcomes Stage 1 Creatinine criteria for AKI
  • Phase 2 and phase 3 of the trial will use a machine-learning based algorithm to target enrollment to those patients expected to derive benefit from alerting, based upon our experience in the prior trial period.

Exclusion Criteria:

  • Prior randomization
  • Admission to hospice service
  • End-stage renal disease
  • Initial hospital creatinine greater than 4.0mg/dl.

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 identifier (NCT number): NCT02786277

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Contact: Francis P Wilson, MD MSCE 2037371704

Sponsors and Collaborators
Yale University
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Responsible Party: Yale University Identifier: NCT02786277    
First Posted: May 30, 2016    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases