Learning Alerts for Acute Kidney Injury

NCT02786277 | Completed Results DMC

• 2 other identifiers: YALEAKIALERTLEARN1R01DK113191-01A1
• Study Type: interventional
• Target: 2,046
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to determine whether the use of uplift (also known as Conditional Average Treatment Effect - CATE) modeling to empirically identify patients expected to benefit the most from AKI alerting and to target AKI alerts to these patients will reduce the rates of AKI progression, dialysis, and mortality.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With Progression to a Higher Stage of AKI OR Dialysis OR Death

  Progression of AKI is defined as the increase in KDIGO stage from the time of randomization to the present. For patients who are discharged, we will impute 14-day creatinine using the last observation carried forward method. Dialysis is defined as the receipt of hemodialysis, continuous renal replacement therapy, or peritoneal dialysis. Isolated ultrafiltration treatments will not be included. Mortality will be determined from hospital administrative records.

  Within 14 days from randomization

Secondary Outcomes (12)

• 14-day Mortality

  Assessed from point of randomization to date of death within 14 days of randomization

• Inpatient Mortality

  Assessed from point of randomization to date of death from any cause, up to one year post-randomization

• 14-day Dialysis

  Assessed from point of randomization to date of first documented dialysis order, within 14 days of randomization

• Inpatient Dialysis

  Assess from point of randomization to date of first documented dialysis order during index hospitalization, up to one year post-randomization

• Discharge on Dialysis

  Assessed at point of discharge from index hospitalization, up to one year post-randomization

Study Arms (2)

Recommended

EXPERIMENTAL

Those whose uplift score represents a probability of benefit greater than 0.5 will generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will not generate an alert.

Other: Alert

Anti-recommended

EXPERIMENTAL

Those whose uplift score represents a probability of benefit greater than 0.5 will not generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will generate an alert.

Other: Alert

Interventions

Alert OTHER

An alert informing the provider of the presence of acute kidney injury will be fired.

Anti-recommended; Recommended

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 18 years
• Admitted to a participating hospital
• Has AKI as defined by creatinine criteria:
• mg/dl increase in inpatient serum creatinine over 48 hours OR
• % relative increase in inpatient serum creatinine over 7 days

You may not qualify if:

• Dialysis order prior to AKI onset
• Initial creatinine ≥ 4.0 mg/dl
• Prior admission in which patient was randomized
• Admission to hospice service or comfort measures only order
• ESKD diagnosis code
• Kidney transplant within six months
• Opted out of electronic health record research

Sponsors & Collaborators

• Yale University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

This trial was randomized at the patient level, introducing the possibility of bias towards the null. It was conducted within a single health system, limiting generalizability. The alert was largely informational with no patient-specific recommendations (not accounting for AKI heterogeneity).

Results Point of Contact

• Title: F. Perry Wilson
• Organization: Yale University

francis.p.wilson@yale.edu

203-737-1704

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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2016
• First Posted: May 30, 2016
• Study Start: February 15, 2024
• Primary Completion: August 14, 2024
• Study Completion: May 3, 2025
• Last Updated: October 8, 2025
• Results First Posted: October 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Upon publication of results; indefinitely

Locations

US (1)