Trial Outcomes & Findings for Learning Alerts for Acute Kidney Injury (NCT NCT02786277)

NCT ID: NCT02786277

Last Updated: 2025-10-08

Results Overview

Progression of AKI is defined as the increase in KDIGO stage from the time of randomization to the present. For patients who are discharged, we will impute 14-day creatinine using the last observation carried forward method. Dialysis is defined as the receipt of hemodialysis, continuous renal replacement therapy, or peritoneal dialysis. Isolated ultrafiltration treatments will not be included. Mortality will be determined from hospital administrative records.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 2046 participants
• Primary outcome timeframe: Within 14 days from randomization
• Results posted on: 2025-10-08

Participant Flow

Recruitment occurred at 4 hospital sites across the Yale New Haven Hospital System. Identification of eligible patient subjects was performed within the Epic electronic medical record system based on inclusion and exclusion criteria by an algorithm embedded into the best practice alert. Randomization occurred the moment the best practice build identified a patient as being eligible.

Participant milestones

Measure	Recommended Those whose uplift score represents a probability of benefit greater than 0.5 will generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will not generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.	Anti-recommended Those whose uplift score represents a probability of benefit greater than 0.5 will not generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.
Overall Study STARTED	1002	1044
Overall Study COMPLETED	1002	1044
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Learning Alerts for Acute Kidney Injury

Baseline characteristics by cohort

Measure	Recommended n=1002 Participants Those whose uplift score represents a probability of benefit greater than 0.5 will generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will not generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.	Anti-recommended n=1044 Participants Those whose uplift score represents a probability of benefit greater than 0.5 will not generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.	Total n=2046 Participants Total of all reporting groups
Age, Continuous	64.5 Years n=5 Participants	63.2 Years n=7 Participants	63.7 Years n=5 Participants
Sex/Gender, Customized Female	537 Participants n=5 Participants	503 Participants n=7 Participants	1040 Participants n=5 Participants
Race/Ethnicity, Customized Black	188 Participants n=5 Participants	206 Participants n=7 Participants	394 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	108 Participants n=5 Participants	140 Participants n=7 Participants	248 Participants n=5 Participants
Creatinine mg/dL	1.5 mg/dL n=5 Participants	1.5 mg/dL n=7 Participants	1.5 mg/dL n=5 Participants
Diastolic blood pressure (mmHg)	67 mmHg n=5 Participants	68 mmHg n=7 Participants	68 mmHg n=5 Participants
Pulse (bpm)	80 beats per minute n=5 Participants	80 beats per minute n=7 Participants	80 beats per minute n=5 Participants
Peripheral Capillary Oxygen Saturation (SpO2, %)	97 percent oxygen saturation n=5 Participants	97 percent oxygen saturation n=7 Participants	97 percent oxygen saturation n=5 Participants
Systolic blood pressure (mmHg)	118 mmHg n=5 Participants	118 mmHg n=7 Participants	118 mmHg n=5 Participants

PRIMARY outcome

Timeframe: Within 14 days from randomization

Progression of AKI is defined as the increase in KDIGO stage from the time of randomization to the present. For patients who are discharged, we will impute 14-day creatinine using the last observation carried forward method.

Dialysis is defined as the receipt of hemodialysis, continuous renal replacement therapy, or peritoneal dialysis. Isolated ultrafiltration treatments will not be included.

Mortality will be determined from hospital administrative records.

Outcome measures

Measure	Recommended n=1002 Participants Those whose uplift score represents a probability of benefit greater than 0.5 will generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will not generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.	Anti-recommended n=1044 Participants Those whose uplift score represents a probability of benefit greater than 0.5 will not generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.
Proportion of Patients With Progression to a Higher Stage of AKI OR Dialysis OR Death	190 Participants	193 Participants

SECONDARY outcome

Timeframe: Assessed from point of randomization to date of death within 14 days of randomization

Proportion of patients who expire from any cause

Outcome measures

Measure	Recommended n=1002 Participants Those whose uplift score represents a probability of benefit greater than 0.5 will generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will not generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.	Anti-recommended n=1044 Participants Those whose uplift score represents a probability of benefit greater than 0.5 will not generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.
14-day Mortality	72 Participants	58 Participants

SECONDARY outcome

Timeframe: Assessed from point of randomization to date of death from any cause, up to one year post-randomization

Proportion of patients who expire from any cause

Outcome measures

Measure	Recommended n=1002 Participants Those whose uplift score represents a probability of benefit greater than 0.5 will generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will not generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.	Anti-recommended n=1044 Participants Those whose uplift score represents a probability of benefit greater than 0.5 will not generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.
Inpatient Mortality	169 Participants	185 Participants

SECONDARY outcome

Timeframe: Assessed from point of randomization to date of first documented dialysis order, within 14 days of randomization

Proportion of patients who receive dialysis (hemodialysis, continuous renal replacement therapy, or peritoneal dialysis)

Outcome measures

Measure	Recommended n=1002 Participants Those whose uplift score represents a probability of benefit greater than 0.5 will generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will not generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.	Anti-recommended n=1044 Participants Those whose uplift score represents a probability of benefit greater than 0.5 will not generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.
14-day Dialysis	38 Participants	37 Participants

SECONDARY outcome

Timeframe: Assess from point of randomization to date of first documented dialysis order during index hospitalization, up to one year post-randomization

Proportion of patients who receive dialysis (hemodialysis, continuous renal replacement therapy, or peritoneal dialysis)

Outcome measures

Measure	Recommended n=1002 Participants Those whose uplift score represents a probability of benefit greater than 0.5 will generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will not generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.	Anti-recommended n=1044 Participants Those whose uplift score represents a probability of benefit greater than 0.5 will not generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.
Inpatient Dialysis	39 Participants	41 Participants

SECONDARY outcome

Timeframe: Assessed at point of discharge from index hospitalization, up to one year post-randomization

Assessed as active orders for dialysis at point of discharge from index hospitalization

Outcome measures

Measure	Recommended n=1002 Participants Those whose uplift score represents a probability of benefit greater than 0.5 will generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will not generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.	Anti-recommended n=1044 Participants Those whose uplift score represents a probability of benefit greater than 0.5 will not generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.
Discharge on Dialysis	28 Participants	22 Participants

SECONDARY outcome

Timeframe: Assessed from the date of randomization to 14 days post randomization

Progression to Stage 2 AKI is defined as a doubling of serum creatinine between randomization and 14 days post randomization, and is considered a worsening of AKI.

Outcome measures

Measure	Recommended n=1002 Participants Those whose uplift score represents a probability of benefit greater than 0.5 will generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will not generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.	Anti-recommended n=1044 Participants Those whose uplift score represents a probability of benefit greater than 0.5 will not generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.
Progression to Stage 2 AKI	91 Participants	103 Participants

SECONDARY outcome

Timeframe: Assessed from the date of randomization to 14 days post randomization

Progression to Stage 3 AKI is defined as a tripling of serum creatinine between the date of randomization and 14 days post randomization, and is considered a worsening of AKI.

Outcome measures

Measure	Recommended n=1002 Participants Those whose uplift score represents a probability of benefit greater than 0.5 will generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will not generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.	Anti-recommended n=1044 Participants Those whose uplift score represents a probability of benefit greater than 0.5 will not generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.
Progression to Stage 3 AKI	72 Participants	66 Participants

SECONDARY outcome

Timeframe: Assessed from the date of randomization to the cessation of AKI during index hospitalization, up to one year

Defined as the time in hours between AKI onset and AKI cessation during index hospitalization

Outcome measures

Measure	Recommended n=1002 Participants Those whose uplift score represents a probability of benefit greater than 0.5 will generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will not generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.	Anti-recommended n=1044 Participants Those whose uplift score represents a probability of benefit greater than 0.5 will not generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.
Duration of AKI	26.9 Hours Interval 22.5 to 50.1	27.7 Hours Interval 22.3 to 50.6

SECONDARY outcome

Timeframe: Assessed from discharge date of index hospitalization to 30 days post discharge date

Proportion of patients with readmission within 30 days of index hospitalization discharge

Outcome measures

Measure	Recommended n=1002 Participants Those whose uplift score represents a probability of benefit greater than 0.5 will generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will not generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.	Anti-recommended n=1044 Participants Those whose uplift score represents a probability of benefit greater than 0.5 will not generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.
30 Day Readmission Rate	123 Participants	187 Participants

SECONDARY outcome

Timeframe: Assessed from point of randomization to date of discharge from index hospitalization, up to one year

Population: The data for this outcome were not collected and will not be accessed in the future. During outcome assessment, PIs were unable to get access to financial data to assess this outcome due to lack of institutional approval, therefore, no participants were analyzed. As this is the only financial-based outcome of the trial, this is the only outcome affected by this circumstance.

Total cost of index hospitalization

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed from date of randomization to date of discharge from index hospitalization, up to one year

Proportion of patients with chart documentation of AKI as assessed by post-discharge ICD-10 codes

Outcome measures

Measure	Recommended n=1002 Participants Those whose uplift score represents a probability of benefit greater than 0.5 will generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will not generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.	Anti-recommended n=1044 Participants Those whose uplift score represents a probability of benefit greater than 0.5 will not generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.
Chart Documentation of AKI	442 Participants	505 Participants

SECONDARY outcome

Timeframe: 24 hours from randomization to discharge, up to one year post randomization

Contrast administration (de novo order of IV contrast agent within 24 hours of randomization), fluid administration (within 24 hours of randomization), aminoglycoside administration (de novo order within 24 hours of randomization), NSAID administration/cessation (de novo order or cessation of order/absence of de novo order of NSAID within 24 hours of randomization), ACE inhibitor administration/cessation, urinalysis order (with or without microscopy within 24 hours of randomization), documentation of AKI (by ICD-9 and ICD-10 codes during index hospitalization), monitoring of creatinine (at least one serum creatinine measurement within 36 hours of randomization), documentation of urine output (within 24 hours of randomization), renal consult order during index hospitalization. Each metric is binary. Outcome is reported as a composite best practice outcome representing the proportion of best practices achieved per subject.

Outcome measures

Measure	Recommended n=1002 Participants Those whose uplift score represents a probability of benefit greater than 0.5 will generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will not generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.	Anti-recommended n=1044 Participants Those whose uplift score represents a probability of benefit greater than 0.5 will not generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will generate an alert. Alert: An alert informing the provider of the presence of acute kidney injury will be fired.
Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization	.6 Proportion achieved per subject Interval 0.5 to 0.7	.6 Proportion achieved per subject Interval 0.5 to 0.7

Adverse Events

Recommended

Serious events: 0 serious events

Other events: 0 other events

Deaths: 169 deaths

Anti-recommended

Serious events: 0 serious events

Other events: 0 other events

Deaths: 185 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

F. Perry Wilson

Yale University

Phone: 203-737-1704

Email: francis.p.wilson@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place