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Trial record 18 of 221 for:    Recruiting, Not yet recruiting, Available Studies | Acute kidney injury

Optimizing Electronic Alerts for Acute Kidney Injury

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ClinicalTrials.gov Identifier: NCT02753751
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
This study will enroll hospitalized adults with acute kidney injury (AKI) and randomize them to usual care versus an electronic alert coupled to a "best practices" order set.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Other: AKI 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. The primary outcome will be a composite of progression of acute kidney injury, dialysis and death.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6030 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Optimizing Electronic Alerts for Acute Kidney Injury
Actual Study Start Date : March 26, 2018
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : December 1, 2022

Arm Intervention/treatment
No Intervention: Usual Care
No alert will be fired.
Experimental: Electronic AKI Alert
A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves.
Other: AKI Alert
Provider's will receive a "pop-up" alert in the electronic health record until AKI is documented in the problem list or AKI resolves.




Primary Outcome Measures :
  1. Composite of progression of AKI, inpatient dialysis, or inpatient death [ Time Frame: 14 days from randomization ]

    Progression of AKI is defined by an increase in KDIGO creatinine stage from that present at the time of randomization.

    Dialysis is defined by the receipt of hemodialysis, continuous renal replacement therapy or peritoneal dialysis. Isolated ultrafiltration treatments (for the purpose of volume removal) will not be included.

    Mortality will be determined from hospital administrative records.



Secondary Outcome Measures :
  1. Mortality [ Time Frame: 14 days from randomization ]
    14-day or inpatient mortality

  2. Dialysis [ Time Frame: 14 days from randomization ]
    14-day, inpatient, or discharged on dialysis

  3. AKI Progression [ Time Frame: 14 days from randomization ]
    Percent of patients who progress to stage 2 AKI and to stage 3 AKI

  4. AKI Duration [ Time Frame: 14 days from randomization ]
    Time in hours between AKI onset and AKI cessation during index hospitalization

  5. Readmission Rate [ Time Frame: 30 days from randomization ]
    30 day readmission rate

  6. Index Hospitalization Cost [ Time Frame: Index hospitalization through discharge ]
    Cost of index hospitalization

  7. Proportion of AKI "best practices" achieved per subject during index hospitalization [ Time Frame: 24 hours from randomization to discharge ]

    Best practices assessed include: Avoidance of nephrotoxins (cessation of order or absence of de novo order of IV constrast agent, aminoglycoside, NSAID, or ACE inhibitor within 24 hours of randomization), fluid administration (administration of fluids within 24 hours of randomization), urinalysis order (with or without microscopy within 24 hours of randomization), documentation of AKI (by ICD-9 and ICD-10 codes during index hospitalization), monitoring of creatinine (at least one serum creatinine measurement occurring within 36 hours of randomization), documentation of urine output (within 24 hours of randomization), renal consult order during index hospitalization.

    Each metric above is binary. Outcome is reported as a composite best practice outcome representing the proportion of best practices achieved per subject.


  8. Number of subjects with chart documentation of AKI [ Time Frame: Index hospitalization ]
    Proportion of subjects with chart documentation of AKI by post-discharge ICD-10 codes and by chart adjudication



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:

  • Adult ≥ 18 years admitted to a participating study hospital
  • Acute Kidney Injury as defined by KDIGO consensus creatinine criteria (0.3mg/dl increase in serum creatinine over 48 hours or 50% relative increase over 7 days).

Exclusion Criteria:

  • ESKD diagnosis code
  • Dialysis order prior to AKI onset
  • Initial creatinine >=4.0mg/dl
  • Prior admission in which patient was randomized.
  • Admission to hospice service or comfort measures only order
  • Kidney transplant within 6 months

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): NCT02753751


Contacts
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Contact: Francis P Wilson, MD MSCE 2037371704 francis.p.wilson@yale.edu

Locations
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United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06520
Contact: Francis P Wilson, MD, MSCE    203-737-1704    francis.p.wilson@yale.edu   
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Francis P Wilson, MD MSCE Yale University

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02753751     History of Changes
Other Study ID Numbers: YALEAKIALERT
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified aggregate data for the primary and secondary outcomes will be made available.
Supporting Materials: Study Protocol
Time Frame: Data will be available within one year of completion.

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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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Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases