Personalized Recommendations for Acute Kidney Injury (AKI) Care

Last updated: June 7, 2024
Sponsor: Yale University
Overall Status: Completed

Phase

N/A

Condition

Renal Failure

Kidney Disease

Kidney Failure

Treatment

Kidney Action Team Recommendations

Clinical Study ID

NCT04040296
2000026203
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adults ≥ 18 years admitted to a participating hospital (six hospitals in the YaleNew Haven Health system and two hospitals of the John Hopkins University Healthsystem)

  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

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 andthe Kidney Action Team will directly notify the treating team.

  1. Pre-existing CKD stage V or End Stage Kidney Disease

  2. Initial hospital creatinine > 4.0 mg/dl

  3. Patients who have been seen by nephrology or already have a nephrology consult

Study Design

Total Participants: 4000
Treatment Group(s): 1
Primary Treatment: Kidney Action Team Recommendations
Phase:
Study Start date:
October 29, 2021
Estimated Completion Date:
February 22, 2024

Study 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.

Connect with a study center

  • Yale New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Site Not Available

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