Trial Outcomes & Findings for Personalized Recommendations for Acute Kidney Injury (AKI) Care (NCT 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

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

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

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=5 Participants	71.9 Years n=7 Participants	71.9 Years n=5 Participants
Sex: Female, Male Female	964 Participants n=5 Participants	910 Participants n=7 Participants	1874 Participants n=5 Participants
Sex: Female, Male Male	1040 Participants n=5 Participants	1089 Participants n=7 Participants	2129 Participants n=5 Participants
Race/Ethnicity, Customized Black	467 participants n=5 Participants	464 participants n=7 Participants	931 participants n=5 Participants
Race/Ethnicity, Customized White	1336 participants n=5 Participants	1325 participants n=7 Participants	2661 participants n=5 Participants
Race/Ethnicity, Customized Other	201 participants n=5 Participants	210 participants n=7 Participants	411 participants n=5 Participants
Race/Ethnicity, Customized Hispanic ethnicity, n (%)	170 participants n=5 Participants	171 participants n=7 Participants	341 participants n=5 Participants
Hypertension, n (%)	1645 Participants n=5 Participants	1602 Participants n=7 Participants	3247 Participants n=5 Participants
Diabetes mellitus, n (%)	957 Participants n=5 Participants	927 Participants n=7 Participants	1884 Participants n=5 Participants
Congestive Heart Failure, n (%)	913 Participants n=5 Participants	872 Participants n=7 Participants	1785 Participants n=5 Participants
Chronic Kidney Disease, n (%)	825 Participants n=5 Participants	840 Participants n=7 Participants	1665 Participants n=5 Participants
Atrial fibrillation, n (%)	666 Participants n=5 Participants	601 Participants n=7 Participants	1267 Participants n=5 Participants
Chronic obstructive pulmonary disease, n (%)	630 Participants n=5 Participants	577 Participants n=7 Participants	1207 Participants n=5 Participants
Cirrhosis, n (%)	135 Participants n=5 Participants	135 Participants n=7 Participants	270 Participants n=5 Participants
Malignancy, n (%)	110 Participants n=5 Participants	120 Participants n=7 Participants	230 Participants n=5 Participants
Elixhauser comorbidity score	8 units on a scale n=5 Participants	7 units on a scale n=7 Participants	8 units on a scale n=5 Participants
Serum creatinine, median (IQR), mg.dL	1.17 mg/dL n=5 Participants	1.19 mg/dL n=7 Participants	1.18 mg/dL n=5 Participants
Estimated glomerular filtration rate, median (IQR), mL/min	57.7 mL/min n=5 Participants	58.2 mL/min n=7 Participants	57.9 mL/min n=5 Participants
Hospital site, n (%) Yale	1602 Participants n=5 Participants	1598 Participants n=7 Participants	3200 Participants n=5 Participants
Hospital site, n (%) John Hopkins	402 Participants n=5 Participants	401 Participants n=7 Participants	803 Participants n=5 Participants
Hospital service General medical floor	1014 Participants n=5 Participants	983 Participants n=7 Participants	1997 Participants n=5 Participants
Hospital service ICU/SDU units	404 Participants n=5 Participants	382 Participants n=7 Participants	786 Participants n=5 Participants
Hospital service Surgical floor	327 Participants n=5 Participants	340 Participants n=7 Participants	667 Participants n=5 Participants
Hospital service Specialist medical floor	259 Participants n=5 Participants	294 Participants n=7 Participants	553 Participants n=5 Participants
Hospital service- General medical floor under hospitalist care, n (%)	716 Participants n=5 Participants	713 Participants n=7 Participants	1429 Participants n=5 Participants
Hospital service- General medical floor under teaching medical team, n (%)	298 Participants n=5 Participants	270 Participants n=7 Participants	568 Participants n=5 Participants
mSOFA, median (IQR)	2 units on a scale n=5 Participants	2 units on a scale n=7 Participants	2 units on a scale n=5 Participants
AKI stage at diagnosis 0	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
AKI stage at diagnosis 1	1823 Participants n=5 Participants	1825 Participants n=7 Participants	3648 Participants n=5 Participants
AKI stage at diagnosis 2	139 Participants n=5 Participants	132 Participants n=7 Participants	271 Participants n=5 Participants
AKI stage at diagnosis 3	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants
sCR, mg/dL	1.5 mg/dL n=5 Participants	1.52 mg/dL n=7 Participants	1.5 mg/dL n=5 Participants
BUN, md/dL	28.5 mg/dL n=5 Participants	29 mg/dL n=7 Participants	29 mg/dL n=5 Participants
Potassium, mEq/L	4.2 mEq/L n=5 Participants	4.2 mEq/L n=7 Participants	4.2 mEq/L n=5 Participants
Bicarbonate, mEq/L	24 mEq/L n=5 Participants	24 mEq/L n=7 Participants	24 mEq/L n=5 Participants
White blood cell count	9.1 x10^3 cells/uL n=5 Participants	9.4 x10^3 cells/uL n=7 Participants	9.2 x10^3 cells/uL n=5 Participants
Hemoglobin, g/dL	10.6 g/dL n=5 Participants	10.5 g/dL n=7 Participants	10.6 g/dL n=5 Participants
Platelet count	212 x10^3 cells/uL n=5 Participants	211 x10^3 cells/uL n=7 Participants	212 x10^3 cells/uL n=5 Participants
Exposures Antibiotics	533 Participants n=5 Participants	554 Participants n=7 Participants	1087 Participants n=5 Participants
Exposures Contrast	407 Participants n=5 Participants	440 Participants n=7 Participants	847 Participants n=5 Participants
Exposures NSAIDs	176 Participants n=5 Participants	195 Participants n=7 Participants	371 Participants n=5 Participants
Exposures Sustained hypotension	187 Participants n=5 Participants	186 Participants n=7 Participants	373 Participants n=5 Participants
Exposures Vasopressor	11 Participants n=5 Participants	17 Participants n=7 Participants	28 Participants n=5 Participants
Recommendations category General	1931 Participants n=5 Participants	1920 Participants n=7 Participants	3851 Participants n=5 Participants
Recommendations category Volume	1589 Participants n=5 Participants	1606 Participants n=7 Participants	3195 Participants n=5 Participants
Recommendations category Potassium	315 Participants n=5 Participants	307 Participants n=7 Participants	622 Participants n=5 Participants
Recommendations category Acid-base	208 Participants n=5 Participants	200 Participants n=7 Participants	408 Participants n=5 Participants
Recommendations category Renal consult	34 Participants n=5 Participants	36 Participants n=7 Participants	70 Participants n=5 Participants
Recommendations category Medication	1114 Participants n=5 Participants	1069 Participants n=7 Participants	2183 Participants n=5 Participants
Recommendation count, median (IQR)	3 number of recommendations n=5 Participants	3 number of recommendations n=7 Participants	3 number of recommendations n=5 Participants

PRIMARY outcome

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

Outcome measures

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 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.

Outcome measures

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

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

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 randomization

Proportion of patients who expire within 14 days of randomization

Outcome measures

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

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

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

Abinet Aklilu

Yale University

Phone: 203-737-1787

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place