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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kidney Action Team Recommendations | Other | 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. |
| 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, whichever comes first |
| 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. |
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Inclusion Criteria:
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:
Exclusion Criteria:
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Francis P Wilson | Yale Univerisity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25726515 | Background | 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. | |
| 39454050 |
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De-identified aggregate data for the primary and secondary outcomes will be made available.
Data will be made available within one year of completion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Kidney Action Team Recommendations will not be delivered to the primary care teams of randomized patients. |
| FG001 | Kidney Action Team Recommendations | Recommendations made by the Kidney Action Team will be delivered to the patient's primary care team within 2 hours of AKI development. 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 2 hours 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Kidney Action Team Recommendations will not be delivered to the primary care teams of randomized patients. |
| BG001 | Kidney Action Team Recommendations | Recommendations made by the Kidney Action Team will be delivered to the patient's primary care team within 2 hours of AKI detection. 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 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 14 days post randomization or at hospital discharge, whichever comes first |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Kidney Action Team Recommendations will not be delivered to the primary care teams of randomized patients. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abinet Aklilu | Yale University | 203-737-1787 | abinet.aklilu@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 10, 2024 | Feb 27, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| 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 |
| Percent of Patients Who Receive a Kidney Consult Within 14 Days | Percent of participants receiving a kidney consult within 14 days of randomization | 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 | Assessed from the time of randomization to time discharge to hospice (within 14 days post-randomization) |
| Derived |
| 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. |
| 37068906 | Derived | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Hypertension, n (%) | Count of Participants | Participants |
|
| Diabetes mellitus, n (%) | Count of Participants | Participants |
|
| Congestive Heart Failure, n (%) | Count of Participants | Participants |
|
| Chronic Kidney Disease, n (%) | Count of Participants | Participants |
|
| Atrial fibrillation, n (%) | Count of Participants | Participants |
|
| Chronic obstructive pulmonary disease, n (%) | Count of Participants | Participants |
|
| Cirrhosis, n (%) | Count of Participants | Participants |
|
| Malignancy, n (%) | Count of Participants | Participants |
|
| Elixhauser comorbidity score | A comorbidity index score used to quantify comorbid conditions based on the presence of 31 pre-existing conditions (using ICD diagnosis codes) scored as present or not. Single scores range 0 from to 31, with higher scores predicting higher in-hospital mortality rates. | Median | Inter-Quartile Range | units on a scale |
|
| Serum creatinine, median (IQR), mg.dL | Median | Inter-Quartile Range | mg/dL |
|
| Estimated glomerular filtration rate, median (IQR), mL/min | Median | Inter-Quartile Range | mL/min |
|
| Hospital site, n (%) | Count of Participants | Participants |
|
| Hospital service | Count of Participants | Participants |
|
| Hospital service- General medical floor under hospitalist care, n (%) | Count of Participants | Participants |
|
| Hospital service- General medical floor under teaching medical team, n (%) | Count of Participants | Participants |
|
| mSOFA, median (IQR) | The Modified Sequential Organ Failure Assessment score, used to predict mortality in critically ill patients. Each of five organ systems is scored on a scale from 0-4, with 4 indicating the highest dysfunction. The scores are summed to total 0 to 20, with a mSOFA score of 20 indicating highest dysfunction. | Median | Inter-Quartile Range | units on a scale |
|
| AKI stage at diagnosis | AKI staged using Kidney Outcomes Improving Global Outcomes (KDIGO) criteria, whereby stage 1 is defined as an increase in serum creatinine of 0.3mg/dL over 48 hours or a relative increase of 50% from baseline over 7 days, stage 2 is defined by an increase by 2 to < 3 times from the lowest creatinine within the prior 7 days., and stage 3 is defined by an increase of > 3 times from the lowest within the prior 7 days or requirement of dialysis. A higher stage indicates worsening disease state and worse outcomes. | Count of Participants | Participants |
|
| sCR, mg/dL | Median | Inter-Quartile Range | mg/dL |
|
| BUN, md/dL | Median | Inter-Quartile Range | mg/dL |
|
| Potassium, mEq/L | Median | Inter-Quartile Range | mEq/L |
|
| Bicarbonate, mEq/L | Median | Inter-Quartile Range | mEq/L |
|
| White blood cell count | Median | Inter-Quartile Range | x10^3 cells/uL |
|
| Hemoglobin, g/dL | Median | Inter-Quartile Range | g/dL |
|
| Platelet count | Median | Inter-Quartile Range | x10^3 cells/uL |
|
| Exposures | Count of Participants | Participants |
|
| Recommendations category | Recommendations were made upon enrollment within 1-2 hours of AKI detection and prior to randomization and are as such considered part of the exposure, rather than an outcome. | Count of Participants | Participants |
|
| Recommendation count, median (IQR) | Recommendations were made upon enrollment within 1-2 hours of AKI detection and prior to randomization and are as such considered part of the exposure, rather than an outcome. | Median | Inter-Quartile Range | number of recommendations |
|
| OG001 | Kidney Action Team Recommendations | Recommendations made by the Kidney Action Team will be delivered to the patient's primary care team within 2 hours of AKI detection. 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 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. |
|
|
|
| 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. | Posted | Number | Number of recommendations | 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | Assessed from time of randomization to date of death from any cause, within 14 days of randomization |
|
|
|
|
| Secondary | Percent of Patients Who Receive a Kidney Consult Within 14 Days | Percent of participants receiving a kidney consult within 14 days of randomization | Posted | Count of Participants | Participants | Assessed from the time of randomization to time of first kidney consult (within 14 days post-randomization) |
|
|
|
|
| Secondary | Percent of Patients Who Are Discharged to Hospice Care 14 Days | Percent of participants discharged to hospice within 14 days of randomization | Posted | Count of Participants | Participants | Assessed from the time of randomization to time discharge to hospice (within 14 days post-randomization) |
|
|
|
|
| 185 |
| 2,004 |
| 0 |
| 2,004 |
| 0 |
| 2,004 |
| EG001 | Kidney Action Team Recommendations | Recommendations made by the Kidney Action Team will be delivered to the patient's primary care team within 60 minutes of AKI development. 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 60 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. | 191 | 1,999 | 0 | 1,999 | 0 | 1,999 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |