Personalized Recommendations for Acute Kidney Injury (AKI) Care

NCT04040296 | Completed Results DMC

• 1 other identifier: 2000026203
• Study Type: interventional
• Target: 4,003
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized clinical trial of a "Kidney Action Team", which will provide timely, personalized recommendations for the diagnosis and initial treatment of hospitalized patients with Acute Kidney Injury (AKI).

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Composite Outcome Showing the Percentage of Participants With Any One of the Following: 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. The rates of the primary outcome will be compared between the study arms using the Cochrane-Mantel-Haenszel chi-square test, accounting for stratification by hospital.

  14 days post randomization or at hospital discharge, whichever comes first

Secondary Outcomes (6)

• Percentage of Recommendations Implemented by the Primary Care Team

  24 hours after randomization

• Percentage of Patients With Progression of Acute Kidney Injury

  Assessed from time of randomization to time of AKI progression (within 14 days post randomization)

• Percentage of Patients Who Receive Inpatient Dialysis

  Assessed from time of randomization to time of receipt of inpatient dialysis (within 14 days post randomization)

• Percentage of Inpatient Mortality

  Assessed from time of randomization to date of death from any cause, within 14 days of randomization

• Percent of Patients Who Receive a Kidney Consult Within 14 Days

  Assessed from the time of randomization to time of first kidney consult (within 14 days post-randomization)

Study Arms (2)

Usual Care

NO INTERVENTION

Kidney Action Team Recommendations will not be delivered to the primary care teams of randomized patients.

Kidney Action Team Recommendations

EXPERIMENTAL

Recommendations made by the Kidney Action Team will be delivered to the patient's primary care team within 2 hours of AKI detection.

Other: Kidney Action Team Recommendations

Interventions

Kidney Action Team Recommendations OTHER

Upon review of the patient's medical information, the Kidney Action Team will create personalized recommendations that will be delivered to the patient's primary care team via a specialized note in the electronic medical record system within 2 hours of AKI detection. The attending of record will be identified as a cosigner to ensure that a member of the care team is made aware of the note's presence.

Kidney Action Team Recommendations

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 (six hospitals in the Yale New Haven Health system and two hospitals of the John Hopkins University Health system)
• Stage 1 Acute Kidney Injury as defined by KDIGO creatinine criteria:
• mg/dl increase in inpatient serum creatine over 48 hours OR
• % relative increase in inpatient serum creatinine over 168 hours

You may not qualify if:

• Admission to hospice service or comfort measures only order
• Recipient of a solid organ transplant
• Immediate dialytic indication determined by the following:
• serum K \>/= 7
• arterial pH \< 7.15
• BUN \> 150 mg/dL
• acute ingestion of dialyzable toxins
• refractory volume overload
• Patients who meet any of these critical values will not be enrolled in the trial and the Kidney Action Team will directly notify the treating team.
• Pre-existing CKD stage V or End Stage Kidney Disease
• Initial hospital creatinine \> 4.0 mg/dl
• Patients who have been seen by nephrology or already have a nephrology consult
• Status post-nephrectomy (partial or radical) during index admission

Sponsors & Collaborators

• Yale University: lead
• Johns Hopkins University: collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Related Publications (3)

• 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: 25726515 BACKGROUND

• Aklilu AM, Menez S, Baker ML, Brown D, Dircksen KK, Dunkley KA, Gaviria SC, Farrokh S, Faulkner SC, Jones C, Kadhim BA, Le D, Li F, Makhijani A, Martin M, Moledina DG, Coronel-Moreno C, O'Connor KD, Shelton K, Shvets K, Srialluri N, Tan JW, Testani JM, Corona-Villalobos CP, Yamamoto Y, Parikh CR, Wilson FP; KAT-AKI Team. Early, Individualized Recommendations for Hospitalized Patients With Acute Kidney Injury: A Randomized Clinical Trial. JAMA. 2024 Dec 24;332(24):2081-2090. doi: 10.1001/jama.2024.22718.

  PMID: 39454050 DERIVED

• Aklilu AM, O'Connor KD, Martin M, Yamamoto Y, Coronel-Moreno C, Shvets K, Jones C, Kadhim B, Corona-Villalobos CP, Baker ML, Tan J, Freeman N, Groener M, Menez S, Brown D, Culli SE, Lindsley J, Orias M, Parikh C, Smith A, Sundararajan A, Wilson FP. Personalised recommendations for hospitalised patients with Acute Kidney Injury using a Kidney Action Team (KAT-AKI): protocol and early data of a randomised controlled trial. BMJ Open. 2023 Apr 17;13(4):e071968. doi: 10.1136/bmjopen-2023-071968.

  PMID: 37068906 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Timely notice, adherence and implementation of recommendations by providers was not guaranteed. Limited windows of time for enrollment may have introduced bias that affected outcomes. Given the bundled nature of the recommendations, the unique effects of a given recommendation could not be determined. Finally, though the structured recommendation form was broad and included an option for free-text recommendations, it is possible that other recommendations may have led to different effects.

Results Point of Contact

• Title: Abinet Aklilu
• Organization: Yale University

abinet.aklilu@yale.edu

203-737-1787

Study Officials

• Francis P Wilson

  Yale Univerisity

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: July 31, 2019
• Study Start: October 29, 2021
• Primary Completion: February 22, 2024
• Study Completion: February 22, 2024
• Last Updated: July 17, 2025
• Results First Posted: July 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be made available within one year of completion.

Locations

US (1)