Acute Kidney Injury
Conditions
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 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.
Interventions
OTHERKidney 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.
Sponsors
Johns Hopkins University
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 7. Status post-nephrectomy (partial or radical) during index admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Outcome Showing the Percentage of Participants With Any One of the Following: Progression of AKI, Inpatient Dialysis, or Inpatient Death | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Progression of Acute Kidney Injury | Assessed from time of randomization to time of AKI progression (within 14 days post randomization) | 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 |
| Percentage of Patients Who Receive Inpatient Dialysis | Assessed from time of randomization to time of receipt of inpatient dialysis (within 14 days post randomization) | Percentage of patients who receive hemodialysis, continuous renal replacement, or peritoneal dialysis during index hospitalization within 14 days of randomization |
| Percentage of Recommendations Implemented by the Primary Care Team | 24 hours after randomization | 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. |
| Percent of Patients Who Receive a Kidney Consult Within 14 Days | Assessed from the time of randomization to time of first kidney consult (within 14 days post-randomization) | Percent of participants receiving a kidney consult within 14 days of randomization |
| Percent of Patients Who Are Discharged to Hospice Care 14 Days | Assessed from the time of randomization to time discharge to hospice (within 14 days post-randomization) | Percent of participants discharged to hospice within 14 days of randomization |
| Percentage of Inpatient Mortality | Assessed from time of randomization to date of death from any cause, within 14 days of randomization | Proportion of patients who expire within 14 days of randomization |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Kidney Action Team Recommendations will not be delivered to the primary care teams of randomized patients. | 2,004 |
| 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. | 1,999 |
| Total | 4,003 |
Baseline characteristics
| Characteristic | Total | Kidney Action Team Recommendations | Usual Care |
|---|---|---|---|
| Age, Continuous | 71.9 Years | 71.9 Years | 71.8 Years |
| AKI stage at diagnosis 0 | 39 Participants | 19 Participants | 20 Participants |
| AKI stage at diagnosis 1 | 3648 Participants | 1825 Participants | 1823 Participants |
| AKI stage at diagnosis 2 | 271 Participants | 132 Participants | 139 Participants |
| AKI stage at diagnosis 3 | 45 Participants | 23 Participants | 22 Participants |
| Atrial fibrillation, n (%) | 1267 Participants | 601 Participants | 666 Participants |
| Bicarbonate, mEq/L | 24 mEq/L | 24 mEq/L | 24 mEq/L |
| BUN, md/dL | 29 mg/dL | 29 mg/dL | 28.5 mg/dL |
| Chronic Kidney Disease, n (%) | 1665 Participants | 840 Participants | 825 Participants |
| Chronic obstructive pulmonary disease, n (%) | 1207 Participants | 577 Participants | 630 Participants |
| Cirrhosis, n (%) | 270 Participants | 135 Participants | 135 Participants |
| Congestive Heart Failure, n (%) | 1785 Participants | 872 Participants | 913 Participants |
| Diabetes mellitus, n (%) | 1884 Participants | 927 Participants | 957 Participants |
| Elixhauser comorbidity score | 8 units on a scale | 7 units on a scale | 8 units on a scale |
| Estimated glomerular filtration rate, median (IQR), mL/min | 57.9 mL/min | 58.2 mL/min | 57.7 mL/min |
| Exposures Antibiotics | 1087 Participants | 554 Participants | 533 Participants |
| Exposures Contrast | 847 Participants | 440 Participants | 407 Participants |
| Exposures NSAIDs | 371 Participants | 195 Participants | 176 Participants |
| Exposures Sustained hypotension | 373 Participants | 186 Participants | 187 Participants |
| Exposures Vasopressor | 28 Participants | 17 Participants | 11 Participants |
| Hemoglobin, g/dL | 10.6 g/dL | 10.5 g/dL | 10.6 g/dL |
| Hospital service General medical floor | 1997 Participants | 983 Participants | 1014 Participants |
| Hospital service ICU/SDU units | 786 Participants | 382 Participants | 404 Participants |
| Hospital service Specialist medical floor | 553 Participants | 294 Participants | 259 Participants |
| Hospital service Surgical floor | 667 Participants | 340 Participants | 327 Participants |
| Hospital service- General medical floor under hospitalist care, n (%) | 1429 Participants | 713 Participants | 716 Participants |
| Hospital service- General medical floor under teaching medical team, n (%) | 568 Participants | 270 Participants | 298 Participants |
| Hospital site, n (%) John Hopkins | 803 Participants | 401 Participants | 402 Participants |
| Hospital site, n (%) Yale | 3200 Participants | 1598 Participants | 1602 Participants |
| Hypertension, n (%) | 3247 Participants | 1602 Participants | 1645 Participants |
| Malignancy, n (%) | 230 Participants | 120 Participants | 110 Participants |
| mSOFA, median (IQR) | 2 units on a scale | 2 units on a scale | 2 units on a scale |
| Platelet count | 212 x10^3 cells/uL | 211 x10^3 cells/uL | 212 x10^3 cells/uL |
| Potassium, mEq/L | 4.2 mEq/L | 4.2 mEq/L | 4.2 mEq/L |
| Race/Ethnicity, Customized Black | 931 participants | 464 participants | 467 participants |
| Race/Ethnicity, Customized Hispanic ethnicity, n (%) | 341 participants | 171 participants | 170 participants |
| Race/Ethnicity, Customized Other | 411 participants | 210 participants | 201 participants |
| Race/Ethnicity, Customized White | 2661 participants | 1325 participants | 1336 participants |
| Recommendation count, median (IQR) | 3 number of recommendations | 3 number of recommendations | 3 number of recommendations |
| Recommendations category Acid-base | 408 Participants | 200 Participants | 208 Participants |
| Recommendations category General | 3851 Participants | 1920 Participants | 1931 Participants |
| Recommendations category Medication | 2183 Participants | 1069 Participants | 1114 Participants |
| Recommendations category Potassium | 622 Participants | 307 Participants | 315 Participants |
| Recommendations category Renal consult | 70 Participants | 36 Participants | 34 Participants |
| Recommendations category Volume | 3195 Participants | 1606 Participants | 1589 Participants |
| sCR, mg/dL | 1.5 mg/dL | 1.52 mg/dL | 1.5 mg/dL |
| Serum creatinine, median (IQR), mg.dL | 1.18 mg/dL | 1.19 mg/dL | 1.17 mg/dL |
| Sex: Female, Male Female | 1874 Participants | 910 Participants | 964 Participants |
| Sex: Female, Male Male | 2129 Participants | 1089 Participants | 1040 Participants |
| White blood cell count | 9.2 x10^3 cells/uL | 9.4 x10^3 cells/uL | 9.1 x10^3 cells/uL |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 185 / 2,004 | 191 / 1,999 |
| other Total, other adverse events | 0 / 2,004 | 0 / 1,999 |
| serious Total, serious adverse events | 0 / 2,004 | 0 / 1,999 |
Outcome results
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.
Time frame: 14 days post randomization or at hospital discharge, whichever comes first
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Composite Outcome Showing the Percentage of Participants With Any One of the Following: Progression of AKI, Inpatient Dialysis, or Inpatient Death | 369 Participants |
| Kidney Action Team Recommendations | Composite Outcome Showing the Percentage of Participants With Any One of the Following: Progression of AKI, Inpatient Dialysis, or Inpatient Death | 395 Participants |
p-value: 0.2895% CI: [-1.1, 3.8]Cochran-Mantel-Haenszel
Secondary
Percentage of Inpatient Mortality
Proportion of patients who expire within 14 days of randomization
Time frame: Assessed from time of randomization to date of death from any cause, within 14 days of randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Percentage of Inpatient Mortality | 185 Participants |
| Kidney Action Team Recommendations | Percentage of Inpatient Mortality | 191 Participants |
Comparison: Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.p-value: 0.7295% CI: [-1.5, 2.1]Van Elteren test
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
Time frame: Assessed from time of randomization to time of receipt of inpatient dialysis (within 14 days post randomization)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Percentage of Patients Who Receive Inpatient Dialysis | 30 Participants |
| Kidney Action Team Recommendations | Percentage of Patients Who Receive Inpatient Dialysis | 31 Participants |
Comparison: Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.p-value: 0.8995% CI: [-0.7, 0.8]Van Elteren test
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
Time frame: Assessed from time of randomization to time of AKI progression (within 14 days post randomization)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Percentage of Patients With Progression of Acute Kidney Injury | 261 Participants |
| Kidney Action Team Recommendations | Percentage of Patients With Progression of Acute Kidney Injury | 270 Participants |
Comparison: Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.p-value: 0.6595% CI: [-1.6, 2.6]Van Elteren test
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.
Time frame: 24 hours after randomization
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care | Percentage of Recommendations Implemented by the Primary Care Team | Recommendations completed | 1766 Number of recommendations |
| Usual Care | Percentage of Recommendations Implemented by the Primary Care Team | Recommendations made | 7269 Number of recommendations |
| Kidney Action Team Recommendations | Percentage of Recommendations Implemented by the Primary Care Team | Recommendations completed | 2459 Number of recommendations |
| Kidney Action Team Recommendations | Percentage of Recommendations Implemented by the Primary Care Team | Recommendations made | 7270 Number of recommendations |
Comparison: Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.p-value: <0.00195% CI: [8.1, 11]Van Elteren test
Secondary
Percent of Patients Who Are Discharged to Hospice Care 14 Days
Percent of participants discharged to hospice within 14 days of randomization
Time frame: Assessed from the time of randomization to time discharge to hospice (within 14 days post-randomization)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Percent of Patients Who Are Discharged to Hospice Care 14 Days | 106 Participants |
| Kidney Action Team Recommendations | Percent of Patients Who Are Discharged to Hospice Care 14 Days | 87 Participants |
Comparison: Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.p-value: 0.1795% CI: [-2.3, 0.4]Van Elteren test
Secondary
Percent of Patients Who Receive a Kidney Consult Within 14 Days
Percent of participants receiving a kidney consult within 14 days of randomization
Time frame: Assessed from the time of randomization to time of first kidney consult (within 14 days post-randomization)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Percent of Patients Who Receive a Kidney Consult Within 14 Days | 284 Participants |
| Kidney Action Team Recommendations | Percent of Patients Who Receive a Kidney Consult Within 14 Days | 321 Participants |
Comparison: Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.p-value: 0.3195% CI: [-0.3, 4.1]Van Elteren test