Trial Outcomes & Findings for Personalized Recommendations for Acute Kidney Injury (AKI) Care (NCT NCT04040296)
NCT ID: NCT04040296
Last Updated: 2025-07-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
4003 participants
Primary outcome timeframe
14 days post randomization or at hospital discharge, whichever comes first
Results posted on
2025-07-17
Participant Flow
Participant milestones
| Measure |
Usual Care
Kidney Action Team Recommendations will not be delivered to the primary care teams of randomized patients.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
2004
|
1999
|
|
Overall Study
COMPLETED
|
2004
|
1999
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Personalized Recommendations for Acute Kidney Injury (AKI) Care
Baseline characteristics by cohort
| Measure |
Usual Care
n=2004 Participants
Kidney Action Team Recommendations will not be delivered to the primary care teams of randomized patients.
|
Kidney Action Team Recommendations
n=1999 Participants
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.
|
Total
n=4003 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.8 Years
n=99 Participants
|
71.9 Years
n=107 Participants
|
71.9 Years
n=206 Participants
|
|
Sex: Female, Male
Female
|
964 Participants
n=99 Participants
|
910 Participants
n=107 Participants
|
1874 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1040 Participants
n=99 Participants
|
1089 Participants
n=107 Participants
|
2129 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
467 participants
n=99 Participants
|
464 participants
n=107 Participants
|
931 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
1336 participants
n=99 Participants
|
1325 participants
n=107 Participants
|
2661 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
201 participants
n=99 Participants
|
210 participants
n=107 Participants
|
411 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic ethnicity, n (%)
|
170 participants
n=99 Participants
|
171 participants
n=107 Participants
|
341 participants
n=206 Participants
|
|
Hypertension, n (%)
|
1645 Participants
n=99 Participants
|
1602 Participants
n=107 Participants
|
3247 Participants
n=206 Participants
|
|
Diabetes mellitus, n (%)
|
957 Participants
n=99 Participants
|
927 Participants
n=107 Participants
|
1884 Participants
n=206 Participants
|
|
Congestive Heart Failure, n (%)
|
913 Participants
n=99 Participants
|
872 Participants
n=107 Participants
|
1785 Participants
n=206 Participants
|
|
Chronic Kidney Disease, n (%)
|
825 Participants
n=99 Participants
|
840 Participants
n=107 Participants
|
1665 Participants
n=206 Participants
|
|
Atrial fibrillation, n (%)
|
666 Participants
n=99 Participants
|
601 Participants
n=107 Participants
|
1267 Participants
n=206 Participants
|
|
Chronic obstructive pulmonary disease, n (%)
|
630 Participants
n=99 Participants
|
577 Participants
n=107 Participants
|
1207 Participants
n=206 Participants
|
|
Cirrhosis, n (%)
|
135 Participants
n=99 Participants
|
135 Participants
n=107 Participants
|
270 Participants
n=206 Participants
|
|
Malignancy, n (%)
|
110 Participants
n=99 Participants
|
120 Participants
n=107 Participants
|
230 Participants
n=206 Participants
|
|
Elixhauser comorbidity score
|
8 units on a scale
n=99 Participants
|
7 units on a scale
n=107 Participants
|
8 units on a scale
n=206 Participants
|
|
Serum creatinine, median (IQR), mg.dL
|
1.17 mg/dL
n=99 Participants
|
1.19 mg/dL
n=107 Participants
|
1.18 mg/dL
n=206 Participants
|
|
Estimated glomerular filtration rate, median (IQR), mL/min
|
57.7 mL/min
n=99 Participants
|
58.2 mL/min
n=107 Participants
|
57.9 mL/min
n=206 Participants
|
|
Hospital site, n (%)
Yale
|
1602 Participants
n=99 Participants
|
1598 Participants
n=107 Participants
|
3200 Participants
n=206 Participants
|
|
Hospital site, n (%)
John Hopkins
|
402 Participants
n=99 Participants
|
401 Participants
n=107 Participants
|
803 Participants
n=206 Participants
|
|
Hospital service
General medical floor
|
1014 Participants
n=99 Participants
|
983 Participants
n=107 Participants
|
1997 Participants
n=206 Participants
|
|
Hospital service
ICU/SDU units
|
404 Participants
n=99 Participants
|
382 Participants
n=107 Participants
|
786 Participants
n=206 Participants
|
|
Hospital service
Surgical floor
|
327 Participants
n=99 Participants
|
340 Participants
n=107 Participants
|
667 Participants
n=206 Participants
|
|
Hospital service
Specialist medical floor
|
259 Participants
n=99 Participants
|
294 Participants
n=107 Participants
|
553 Participants
n=206 Participants
|
|
Hospital service- General medical floor under hospitalist care, n (%)
|
716 Participants
n=99 Participants
|
713 Participants
n=107 Participants
|
1429 Participants
n=206 Participants
|
|
Hospital service- General medical floor under teaching medical team, n (%)
|
298 Participants
n=99 Participants
|
270 Participants
n=107 Participants
|
568 Participants
n=206 Participants
|
|
mSOFA, median (IQR)
|
2 units on a scale
n=99 Participants
|
2 units on a scale
n=107 Participants
|
2 units on a scale
n=206 Participants
|
|
AKI stage at diagnosis
0
|
20 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
AKI stage at diagnosis
1
|
1823 Participants
n=99 Participants
|
1825 Participants
n=107 Participants
|
3648 Participants
n=206 Participants
|
|
AKI stage at diagnosis
2
|
139 Participants
n=99 Participants
|
132 Participants
n=107 Participants
|
271 Participants
n=206 Participants
|
|
AKI stage at diagnosis
3
|
22 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
sCR, mg/dL
|
1.5 mg/dL
n=99 Participants
|
1.52 mg/dL
n=107 Participants
|
1.5 mg/dL
n=206 Participants
|
|
BUN, md/dL
|
28.5 mg/dL
n=99 Participants
|
29 mg/dL
n=107 Participants
|
29 mg/dL
n=206 Participants
|
|
Potassium, mEq/L
|
4.2 mEq/L
n=99 Participants
|
4.2 mEq/L
n=107 Participants
|
4.2 mEq/L
n=206 Participants
|
|
Bicarbonate, mEq/L
|
24 mEq/L
n=99 Participants
|
24 mEq/L
n=107 Participants
|
24 mEq/L
n=206 Participants
|
|
White blood cell count
|
9.1 x10^3 cells/uL
n=99 Participants
|
9.4 x10^3 cells/uL
n=107 Participants
|
9.2 x10^3 cells/uL
n=206 Participants
|
|
Hemoglobin, g/dL
|
10.6 g/dL
n=99 Participants
|
10.5 g/dL
n=107 Participants
|
10.6 g/dL
n=206 Participants
|
|
Platelet count
|
212 x10^3 cells/uL
n=99 Participants
|
211 x10^3 cells/uL
n=107 Participants
|
212 x10^3 cells/uL
n=206 Participants
|
|
Exposures
Antibiotics
|
533 Participants
n=99 Participants
|
554 Participants
n=107 Participants
|
1087 Participants
n=206 Participants
|
|
Exposures
Contrast
|
407 Participants
n=99 Participants
|
440 Participants
n=107 Participants
|
847 Participants
n=206 Participants
|
|
Exposures
NSAIDs
|
176 Participants
n=99 Participants
|
195 Participants
n=107 Participants
|
371 Participants
n=206 Participants
|
|
Exposures
Sustained hypotension
|
187 Participants
n=99 Participants
|
186 Participants
n=107 Participants
|
373 Participants
n=206 Participants
|
|
Exposures
Vasopressor
|
11 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Recommendations category
General
|
1931 Participants
n=99 Participants
|
1920 Participants
n=107 Participants
|
3851 Participants
n=206 Participants
|
|
Recommendations category
Volume
|
1589 Participants
n=99 Participants
|
1606 Participants
n=107 Participants
|
3195 Participants
n=206 Participants
|
|
Recommendations category
Potassium
|
315 Participants
n=99 Participants
|
307 Participants
n=107 Participants
|
622 Participants
n=206 Participants
|
|
Recommendations category
Acid-base
|
208 Participants
n=99 Participants
|
200 Participants
n=107 Participants
|
408 Participants
n=206 Participants
|
|
Recommendations category
Renal consult
|
34 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Recommendations category
Medication
|
1114 Participants
n=99 Participants
|
1069 Participants
n=107 Participants
|
2183 Participants
n=206 Participants
|
|
Recommendation count, median (IQR)
|
3 number of recommendations
n=99 Participants
|
3 number of recommendations
n=107 Participants
|
3 number of recommendations
n=206 Participants
|
PRIMARY outcome
Timeframe: 14 days post randomization or at hospital discharge, whichever comes firstProgression 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.
Outcome measures
| Measure |
Usual Care
n=2004 Participants
Kidney Action Team Recommendations will not be delivered to the primary care teams of randomized patients.
|
Kidney Action Team Recommendations
n=1999 Participants
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.
|
|---|---|---|
|
Composite Outcome Showing the Percentage of Participants With Any One of the Following: Progression of AKI, Inpatient Dialysis, or Inpatient Death
|
369 Participants
|
395 Participants
|
SECONDARY outcome
Timeframe: 24 hours after randomizationThe 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.
Outcome measures
| Measure |
Usual Care
n=2004 Participants
Kidney Action Team Recommendations will not be delivered to the primary care teams of randomized patients.
|
Kidney Action Team Recommendations
n=1999 Participants
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.
|
|---|---|---|
|
Percentage of Recommendations Implemented by the Primary Care Team
Recommendations completed
|
1766 Number of recommendations
|
2459 Number of recommendations
|
|
Percentage of Recommendations Implemented by the Primary Care Team
Recommendations made
|
7269 Number of recommendations
|
7270 Number of recommendations
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Usual Care
n=2004 Participants
Kidney Action Team Recommendations will not be delivered to the primary care teams of randomized patients.
|
Kidney Action Team Recommendations
n=1999 Participants
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.
|
|---|---|---|
|
Percentage of Patients With Progression of Acute Kidney Injury
|
261 Participants
|
270 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Usual Care
n=2004 Participants
Kidney Action Team Recommendations will not be delivered to the primary care teams of randomized patients.
|
Kidney Action Team Recommendations
n=1999 Participants
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.
|
|---|---|---|
|
Percentage of Patients Who Receive Inpatient Dialysis
|
30 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Assessed from time of randomization to date of death from any cause, within 14 days of randomizationProportion of patients who expire within 14 days of randomization
Outcome measures
| Measure |
Usual Care
n=2004 Participants
Kidney Action Team Recommendations will not be delivered to the primary care teams of randomized patients.
|
Kidney Action Team Recommendations
n=1999 Participants
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.
|
|---|---|---|
|
Percentage of Inpatient Mortality
|
185 Participants
|
191 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Usual Care
n=2004 Participants
Kidney Action Team Recommendations will not be delivered to the primary care teams of randomized patients.
|
Kidney Action Team Recommendations
n=1999 Participants
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.
|
|---|---|---|
|
Percent of Patients Who Receive a Kidney Consult Within 14 Days
|
284 Participants
|
321 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Usual Care
n=2004 Participants
Kidney Action Team Recommendations will not be delivered to the primary care teams of randomized patients.
|
Kidney Action Team Recommendations
n=1999 Participants
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.
|
|---|---|---|
|
Percent of Patients Who Are Discharged to Hospice Care 14 Days
|
106 Participants
|
87 Participants
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 185 deaths
Kidney Action Team Recommendations
Serious events: 0 serious events
Other events: 0 other events
Deaths: 191 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place