Personalized Recommendations for Acute Kidney Injury (AKI) Care

Personalized Recommendations for Acute Kidney Injury (AKI) Care Using a Kidney Action Team: A Randomized Trial

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).

Study Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Other: Kidney Action Team Recommendations

Detailed Description

Acute Kidney Injury (AKI), defined as an abrupt loss in kidney function, is common, occurring in 5-20% of hospitalized patients, and carries a significant and independent risk of inpatient mortality. International guidelines for the treatment of AKI focus on "best practices" that include appropriate management of drug dosing, the avoidance of kidney-toxic exposures, and careful assessment of fluid and electrolyte balance. Early nephrologist involvement may also improve outcomes in AKI. However, AKI, which is often asymptomatic, is frequently overlooked in a variety of hospital settings and many "best practices" occur infrequently and inconsistently.

The investigators previously conducted a randomized clinical trial testing the efficacy of electronic alerts for AKI, randomizing patients with AKI to usual care, or to an alert group in which a single alert was sent to the patient's primary provider. The study demonstrated clinical equipoise regarding the effectiveness of such alerting, as there was no improvement in the rates of AKI progression, dialysis or mortality among those in the alert group.

Rather than simply making providers aware of AKI, it may be beneficial to provide them with actionable items to increase recognition and rate of best practices. Further, because of the heterogeneous nature of AKI, personalized recommendations tailored to individual patients that are delivered directly to the patient care team may improve AKI outcomes. The aim of this study is to determine, through a single-blind, parallel group, randomized controlled multicenter clinical trial, if personalized recommendations, as delivered by a Kidney Action Team, for the work-up and treatment of AKI will improve patient outcomes. The Kidney Action team will serve as a centralized, remote monitoring service and will consist of a group of highly trained individuals, including an advanced practitioner, a pharmacist and a board-certified nephrologist, dedicated to reviewing enrolled patient's charts and providing recommendations for patient diagnosis and initial work up and care within 30 minutes of AKI onset. Recommendations will span five domains of care, including diagnostic workup, acid/base management, electrolyte management, hemodynamic management, and medication management.

Using the Kidney Disease: Improve Global Outcomes creatinine criteria, inpatients in sites of the Yale New Haven Health System and of the John Hopkins University Health System who develop AKI during the course of their hospitalization will be randomized to either receive usual care, or to an active intervention group in which the recommendations of the Kidney Action Team are delivered to the patient's primary care team in the form of a structured note in the electronic health record to be cosigned by the attending of record. The primary clinical outcome will be a composite of AKI progression, dialysis and death at 14 days post-randomization. The primary process outcome will be the percent of recommendations made that are enacted within 24 hours after randomization.

• Study Type: Interventional
• Enrollment (Estimated): 4000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francis P Wilson, MD MSCE; Phone Number: 2037371704; Email: francis.p.wilson@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale New Haven Hospital
      • Contact: Francis Wilson, MD; Email: francis.p.wilson@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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)

2. Stage 1 Acute Kidney Injury as defined by KDIGO creatinine criteria:

   • 0.3 mg/dl increase in inpatient serum creatine over 48 hours OR
   • 50% relative increase in inpatient serum creatinine over 168 hours

Exclusion Criteria:

1. Admission to hospice service or comfort measures only order
2. Recipient of a solid organ transplant

3. 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.

4. Pre-existing CKD stage V or End Stage Kidney Disease
5. Initial hospital creatinine > 4.0 mg/dl
6. Patients who have been seen by nephrology or already have a nephrology consult

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Kidney Action Team Recommendations will not be delivered to the primary care teams of randomized patients.
Experimental: Kidney Action Team Recommendations; Recommendations made by the Kidney Action Team will be delivered to the patient's primary care team within 30 minutes of AKI development.	Other: Kidney Action Team Recommendations; 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 30 minutes of AKI development. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of recommendations implemented by the primary care team	The AKI Response Team will make recommendations for all randomized patients in both the control group and the intervention group, however, recommendations will only be delivered to the primary care teams of patients in the intervention group. In this way, we can compare the percentage of recommendations that were followed by primary care teams across both groups. This outcome will be assessed by averaging the proportion of recommendations followed within 24 hours between the two study arms using the Van Elteren test to account for stratification by hospital.	24 hours after randomization
Percentage of patients with progression of Acute Kidney Injury	Percentage of patients who progressed from stage 1 to stage 2 or 3 or from stage 2 to stage 3 (based on changes in creatinine) within 14 days of randomization	Assessed from time of randomization to time of AKI progression (within 14 days post randomization)
Percentage of patients who receive inpatient dialysis	Percentage of patients who receive hemodialysis, continuous renal replacement, or peritoneal dialysis during index hospitalization within 14 days of randomization	Assessed from time of randomization to time of receipt of inpatient dialysis (within 14 days post randomization)
Percentage of inpatient mortality	Proportion of patients who expire within 14 days of randomization	Assessed from time of randomization to date of death from any cause, within 14 days of randomization

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Johns Hopkins University
• Investigators: Principal Investigator: Francis P Wilson, Yale Univerisity

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2021
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: July 29, 2019
• First Submitted That Met QC Criteria: July 30, 2019
• First Posted (Actual): July 31, 2019

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: 2000026203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified aggregate data for the primary and secondary outcomes will be made available.
• IPD Sharing Time Frame: Data will be made available within one year of completion.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No