Personalized Recommendations for Acute Kidney Injury (AKI) Care

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04040296
• Other study ID #: 2000026203
• Status: Completed
• Phase: N/A
• Start date: October 29, 2021
• Est. completion date: February 22, 2024

Study information

• Verified date: June 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: February 22, 2024
• Est. primary completion date: February 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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