NCT02753751

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,030

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
1.9 years until next milestone

Study Start

First participant enrolled

March 26, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2020

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

February 10, 2022

Completed
Last Updated

February 10, 2022

Status Verified

January 1, 2022

Enrollment Period

1.8 years

First QC Date

April 25, 2016

Results QC Date

November 8, 2021

Last Update Submit

January 18, 2022

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • Composite of Progression of AKI, Inpatient Dialysis, or Inpatient Death

    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.

    14 days from randomization

Secondary Outcomes (8)

  • Mortality

    14 days from randomization

  • Dialysis

    14 days from randomization

  • AKI Progression

    14 days from randomization

  • AKI Duration

    14 days from randomization

  • Readmission Rate

    30 days from randomization

  • +3 more secondary outcomes

Study Arms (2)

Usual Care

NO INTERVENTION

No alert will be fired.

Electronic AKI Alert

EXPERIMENTAL

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

Interventions

AKI AlertOTHER

Provider's will receive a "pop-up" alert in the electronic health record until AKI is documented in the problem list or AKI resolves.

Electronic AKI Alert

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

Related Publications (5)

  • 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.

    PMID: 25726515BACKGROUND

  • Wissel BD, Percy Z, Zachem TJ, Beaulieu-Jones B, Kohane IS, Goldstein SL, Gecili E, Dexheimer JW. Heterogenous effect of automated alerts on mortality. J Am Med Inform Assoc. 2025 Dec 25:ocaf222. doi: 10.1093/jamia/ocaf222. Online ahead of print.

    PMID: 41445428DERIVED

  • Wissel BD, Percy Z, Zachem TJ, Beaulieu-Jones B, Kohane IS, Goldstein SL, Gecili E, Dexheimer JW. Heterogeneous Effect of Automated Alerts on Mortality. medRxiv [Preprint]. 2025 Aug 13:2025.08.11.25333302. doi: 10.1101/2025.08.11.25333302.

    PMID: 40832403DERIVED

  • Wilson FP, Martin M, Yamamoto Y, Partridge C, Moreira E, Arora T, Biswas A, Feldman H, Garg AX, Greenberg JH, Hinchcliff M, Latham S, Li F, Lin H, Mansour SG, Moledina DG, Palevsky PM, Parikh CR, Simonov M, Testani J, Ugwuowo U. Electronic health record alerts for acute kidney injury: multicenter, randomized clinical trial. BMJ. 2021 Jan 18;372:m4786. doi: 10.1136/bmj.m4786.

    PMID: 33461986DERIVED

  • Mutter M, Martin M, Yamamoto Y, Biswas A, Etropolski B, Feldman H, Garg A, Gourlie N, Latham S, Lin H, Palevsky PM, Parikh C, Moreira E, Ugwuowo U, Wilson FP. Electronic Alerts for Acute Kidney Injury Amelioration (ELAIA-1): a completely electronic, multicentre, randomised controlled trial: design and rationale. BMJ Open. 2019 Jun 1;9(5):e025117. doi: 10.1136/bmjopen-2018-025117.

    PMID: 31154298DERIVED

Related Links

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Limitations and Caveats

Randomization occurred at the patient level, potentially biasing the results towards the null hypothesis. The alert was largely informational with no patient-specific recommendations. The alert was only sent to certain care providers, notably excluding nurses and pharmacists, who might specifically benefit from receipt of the alert. The alert was conducted across six hospitals within a single large health system in the Northeastern United States, limiting generalizability.

Results Point of Contact

Title
Francis P. Wilson
Organization
Yale University
francis.p.wilson@yale.edu
2037376095

Study Officials

  • Francis P Wilson, MD MSCE

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2016

First Posted

April 28, 2016

Study Start

March 26, 2018

Primary Completion

January 6, 2020

Study Completion

January 6, 2020

Last Updated

February 10, 2022

Results First Posted

February 10, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

De-identified aggregate data for the primary and secondary outcomes will be made available.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available within one year of completion.

Locations

US(1)