Clinical trial NCT04040296: Personalized Recommendations for Acute Kidney Injury (AKI) Care
Official title: Personalized Recommendations for Acute Kidney Injury (AKI) Care Using a Kidney Action Team: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2019-07-31
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite outcome showing the percentage of participants with any one of the following: progression of AKI, inpatient dialysis, or inpatient death
timeFrame: 14 days post randomization or at hospital discharge
Secondary outcomes:
measure: Percentage of recommendations implemented by the primary care team
timeFrame: 24 hours after randomization
measure: Percentage of patients with progression of Acute Kidney Injury
timeFrame: Assessed from time of randomization to time of AKI progression (within 14 days post randomization)
measure: Percentage of patients who receive inpatient dialysis
timeFrame: Assessed from time of randomization to time of receipt of inpatient dialysis (within 14 days post randomization)
measure: Percentage of inpatient mortality
timeFrame: Assessed from time of randomization to date of death from any cause, within 14 days of randomization
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale Univerisity
name: Francis P Wilson
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.