Acute Kidney InjuryNCT04040296

Personalized Recommendations for Acute Kidney Injury (AKI) Care

A study testing Kidney Action Team Recommendations in people with Acute Kidney Injury, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Kidney Injury
What is being tested?: Kidney Action Team Recommendations
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4,003 participants
Where: 1 siteUnited States
Study dates: 29 Oct 2021to 22 Feb 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Yale New Haven Hospital
New Haven, Connecticut, 06510

Other trials in United States

About this study

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

Read the 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 60 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.

Conditions: Acute Kidney Injury
Being tested: Kidney Action Team Recommendations
Medical subject headings: Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Kidney Action Team RecommendationsOther
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.

Study groups in NCT04040296
Study group	Role	What they receive
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. Receives: Other: Kidney Action Team Recommendations

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (6)

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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Percent of participants receiving a kidney consult within 14 days of randomization
Measured: Assessed from the time of randomization to time of first kidney consult (within 14 days post-randomization)
Percent of Patients Who Are Discharged to Hospice Care 14 Days
Percent of participants discharged to hospice within 14 days of randomization
Measured: Assessed from the time of randomization to time discharge to hospice (within 14 days post-randomization)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Oct 202122 Feb 2024

First posted31 Jul 2019
Study start29 Oct 2021
Primary completion22 Feb 2024
Study completion22 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 4,003 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04040296
Sponsor's protocol ID: 2000026203
Status last verified: Jun 2025
First submitted: 29 Jul 2019
Last updated: 17 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified aggregate data for the primary and secondary outcomes will be made available.

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.
PubMed 25726515
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.
PubMed 39454050
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.
PubMed 37068906

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Kidney Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Personalized Recommendations for Acute Kidney Injury (AKI) Care Using a Kidney Action Team: A Randomized Trial
ClinicalTrials.gov ID: NCT04040296
Acronym / sponsor ID: 2000026203
Conditions: Acute Kidney Injury
Study type: Interventional
Recruitment status: Completed
Enrolment: 4,003 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: Johns Hopkins University
Study start: 29 Oct 2021 (actual)
Primary completion: 22 Feb 2024 (actual)
Study completion: 22 Feb 2024 (actual)
First posted: 31 Jul 2019 (actual)
Results: Posted 17 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
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	Other: Kidney Action Team RecommendationsRecommendations made by the Kidney Action Team will be delivered to the patient's primary care team within 2 hours of AKI detection.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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:

Key exclusion criteria (13 listed)

Admission to hospice service or comfort measures only order
Recipient of a solid organ transplant
Immediate dialytic indication determined by the following:
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Kidney Action Team RecommendationsUpon 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.	Other	Kidney Action Team Recommendations

Primary outcome

Composite Outcome Showing the Percentage of Participants With Any One of the Following: Progression of AKI, Inpatient Dialysis, or Inpatient Death
Time frame: 14 days post randomization or at hospital discharge, whichever comes first
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.

6 secondary outcomes

Percentage of Recommendations Implemented by the Primary Care Team
Time frame: 24 hours after randomization
Percentage of Patients With Progression of Acute Kidney Injury
Time frame: Assessed from time of randomization to time of AKI progression (within 14 days post randomization)
Percentage of Patients Who Receive Inpatient Dialysis
Time frame: Assessed from time of randomization to time of receipt of inpatient dialysis (within 14 days post randomization)
Percentage of Inpatient Mortality
Time frame: 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
Time frame: Assessed from the time of randomization to time of first kidney consult (within 14 days post-randomization)
Percent of Patients Who Are Discharged to Hospice Care 14 Days
Time frame: Assessed from the time of randomization to time discharge to hospice (within 14 days post-randomization)

Results and safety

Results posted to the registry on 17 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	2,004	2,004
Kidney Action Team Recommendations	1,999	1,999

Primary outcome: Composite Outcome Showing the Percentage of Participants With Any One of the Following: Progression of AKI, Inpatient Dialysis, or Inpatient Death

Time frame: 14 days post randomization or at hospital discharge, whichever comes first. Count of participants. Unit: Participants

Measure	Usual Care n = 2004	Kidney Action Team Recommendations n = 1999
Value	369	395

Usual Care vs Kidney Action Team Recommendations: Difference in percentage: 1.4 (95% CI -1.1 to 3.8), p = 0.28, Cochran-Mantel-Haenszel

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were assessed unsystematically by provider reporting throughout the trial and until study completion, to be reviewed by the internal team and external DSMB. The study lasted 2 years and 4 months, with each subject enrolled for 14 days in which adverse events could be reported.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	0 of 2,004 (0%)	0 of 2,004 (0%)	185 of 2,004
Kidney Action Team Recommendations	0 of 1,999 (0%)	0 of 1,999 (0%)	191 of 1,999

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25726515Wilson 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.
Derived from this study: PubMed 39454050Aklilu 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.
Derived from this study: PubMed 37068906Aklilu 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.
Individual participant dataSharing planned: Yes. De-identified aggregate data for the primary and secondary outcomes will be made available.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Francis P Wilson principal investigator

Yale Univerisity

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Kidney Action Team Recommendations in people with Acute Kidney Injury, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Outcome Showing the Percentage of Participants With Any One of the Following: Progression of AKI, Inpatient Dialysis, or Inpatient Death (time frame: 14 days post randomization or at hospital discharge, whichever comes first). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04040296, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.