Trial Outcomes & Findings for Drug-Targeted Alerts for Acute Kidney Injury (NCT NCT02771977)
NCT ID: NCT02771977
Last Updated: 2024-02-15
Results Overview
Progression of AKI is defined by an increase in KDIGO creatinine stage from time of randomization to the present. Dialysis is defined by the receipt of hemodialysis, continuous renal replacement therapy or peritoneal dialysis. Isolated ultrafiltration treatments will not be included. Mortality will be determined from hospital records.
COMPLETED
NA
5060 participants
14 days from Randomization
2024-02-15
Participant Flow
Recruitment and enrollment was done automatically via our best practice alert, which analyzed hospitalized patients for inclusion and exclusion criteria and, if met, automatically enrolled and randomized patients to the usual care or alert group.
5,839 subjects were assessed for eligibility, with 779 excluded due to either the patient's admission dates being prior to the alert becoming active, the first alert firing after a discharge order, or because the patient was already randomized in a previous hospital admission. 5,060 patients were then randomized to alert versus usual care with zero loss to follow up.
Participant milestones
| Measure |
Usual Care
No alert will be fired.
|
Drug-specific Alert
A drug-specific AKI alert, including information about the drug of interest as well as the presence of AKI will be fired.
Drug-specific alert: A drug-specific alert, informing the provider of the presence of AKI as well as recent exposure to a potentially nephrotoxic agent, will be fired.
|
|---|---|---|
|
Overall Study
STARTED
|
2528
|
2532
|
|
Overall Study
COMPLETED
|
2528
|
2532
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Drug-Targeted Alerts for Acute Kidney Injury
Baseline characteristics by cohort
| Measure |
Usual Care
n=2528 Participants
No alert will be fired.
|
Drug-specific Alert
n=2532 Participants
A drug-specific AKI alert, including information about the drug of interest as well as the presence of AKI will be fired.
Drug-specific alert: A drug-specific alert, informing the provider of the presence of AKI as well as recent exposure to a potentially nephrotoxic agent, will be fired.
|
Total
n=5060 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 Years
n=99 Participants
|
70 Years
n=107 Participants
|
70 Years
n=206 Participants
|
|
Sex: Female, Male
Female
|
1222 Participants
n=99 Participants
|
1231 Participants
n=107 Participants
|
2453 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1306 Participants
n=99 Participants
|
1301 Participants
n=107 Participants
|
2607 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
341 Participants
n=99 Participants
|
350 Participants
n=107 Participants
|
691 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2163 Participants
n=99 Participants
|
2166 Participants
n=107 Participants
|
4329 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
24 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
7 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
40 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
470 Participants
n=99 Participants
|
498 Participants
n=107 Participants
|
968 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1714 Participants
n=99 Participants
|
1683 Participants
n=107 Participants
|
3397 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
296 Participants
n=99 Participants
|
295 Participants
n=107 Participants
|
591 Participants
n=206 Participants
|
|
Hospital Location
Medical Admission
|
1924 Participants
n=99 Participants
|
1937 Participants
n=107 Participants
|
3861 Participants
n=206 Participants
|
|
Hospital Location
ICU
|
598 Participants
n=99 Participants
|
560 Participants
n=107 Participants
|
1158 Participants
n=206 Participants
|
|
Hospital Location
Emergency Department
|
87 Participants
n=99 Participants
|
90 Participants
n=107 Participants
|
177 Participants
n=206 Participants
|
|
Hospital Location
Ward
|
1746 Participants
n=99 Participants
|
1775 Participants
n=107 Participants
|
3521 Participants
n=206 Participants
|
|
Hospital
Hospital 1
|
1250 Participants
n=99 Participants
|
1197 Participants
n=107 Participants
|
2447 Participants
n=206 Participants
|
|
Hospital
Hospital 2
|
591 Participants
n=99 Participants
|
623 Participants
n=107 Participants
|
1214 Participants
n=206 Participants
|
|
Hospital
Hospital 3
|
446 Participants
n=99 Participants
|
464 Participants
n=107 Participants
|
910 Participants
n=206 Participants
|
|
Hospital
Hospital 4
|
241 Participants
n=99 Participants
|
248 Participants
n=107 Participants
|
489 Participants
n=206 Participants
|
|
Comorbidities
Chronic Kidney Disease
|
616 Participants
n=99 Participants
|
671 Participants
n=107 Participants
|
1287 Participants
n=206 Participants
|
|
Comorbidities
Congestive Heart Failure
|
784 Participants
n=99 Participants
|
827 Participants
n=107 Participants
|
1611 Participants
n=206 Participants
|
|
Comorbidities
Chronic Obstructive Pulmonary Disorder (COPD)
|
762 Participants
n=99 Participants
|
776 Participants
n=107 Participants
|
1538 Participants
n=206 Participants
|
|
Comorbidities
Diabetes Mellitus
|
928 Participants
n=99 Participants
|
967 Participants
n=107 Participants
|
1895 Participants
n=206 Participants
|
|
Comorbidities
Hypertension
|
1726 Participants
n=99 Participants
|
1710 Participants
n=107 Participants
|
3436 Participants
n=206 Participants
|
|
Comorbidities
Malignancy
|
563 Participants
n=99 Participants
|
549 Participants
n=107 Participants
|
1112 Participants
n=206 Participants
|
|
Comorbidities
Depression
|
580 Participants
n=99 Participants
|
601 Participants
n=107 Participants
|
1181 Participants
n=206 Participants
|
|
Comorbidities
Liver Disease
|
359 Participants
n=99 Participants
|
310 Participants
n=107 Participants
|
669 Participants
n=206 Participants
|
|
Acute Kidney Injury (AKI) stage at randomization
Stage 0
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Acute Kidney Injury (AKI) stage at randomization
Stage 1
|
2248 Participants
n=99 Participants
|
2279 Participants
n=107 Participants
|
4527 Participants
n=206 Participants
|
|
Acute Kidney Injury (AKI) stage at randomization
Stage 2
|
230 Participants
n=99 Participants
|
191 Participants
n=107 Participants
|
421 Participants
n=206 Participants
|
|
Acute Kidney Injury (AKI) stage at randomization
Stage 3
|
47 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
103 Participants
n=206 Participants
|
|
Estimated Glomerular Filtration Rate (eGFR) on admission
|
61 ml/min/1.73m^2
n=99 Participants
|
60 ml/min/1.73m^2
n=107 Participants
|
60.3 ml/min/1.73m^2
n=206 Participants
|
|
Creatinine at randomization
|
1.5 mg/dL
n=99 Participants
|
1.5 mg/dL
n=107 Participants
|
1.5 mg/dL
n=206 Participants
|
|
Creatinine at admission
|
1.2 mg/dL
n=99 Participants
|
1.2 mg/dL
n=107 Participants
|
1.2 mg/dL
n=206 Participants
|
|
Sodium
|
138 meq/L
n=99 Participants
|
138 meq/L
n=107 Participants
|
138 meq/L
n=206 Participants
|
|
Potassium
|
4.2 meq/L
n=99 Participants
|
4.2 meq/L
n=107 Participants
|
4.2 meq/L
n=206 Participants
|
|
Chloride
|
102 meq/L
n=99 Participants
|
102 meq/L
n=107 Participants
|
102 meq/L
n=206 Participants
|
|
Bicarbonate
|
23 meq/L
n=99 Participants
|
23 meq/L
n=107 Participants
|
23 meq/L
n=206 Participants
|
|
Anion gap
|
12 meq/L
n=99 Participants
|
12 meq/L
n=107 Participants
|
12 meq/L
n=206 Participants
|
|
Blood urea nitrogen (BUN)
|
29 mg/dL
n=99 Participants
|
29 mg/dL
n=107 Participants
|
29 mg/dL
n=206 Participants
|
|
White blood cell count
|
9.6 x1000/uL
n=99 Participants
|
9.5 x1000/uL
n=107 Participants
|
9.6 x1000/uL
n=206 Participants
|
|
Hemoglobin
|
10.6 g/dL
n=99 Participants
|
10.6 g/dL
n=107 Participants
|
10.6 g/dL
n=206 Participants
|
|
Platelet count
|
214 x1000/uL
n=99 Participants
|
213 x1000/uL
n=107 Participants
|
213 x1000/uL
n=206 Participants
|
|
Modified SOFA score
|
3 Scores on a scale
n=99 Participants
|
2 Scores on a scale
n=107 Participants
|
2 Scores on a scale
n=206 Participants
|
|
Exposures prior to AKI
Contrast in prior 72 hours
|
662 Participants
n=99 Participants
|
621 Participants
n=107 Participants
|
1283 Participants
n=206 Participants
|
|
Exposures prior to AKI
Renin angiotensin aldosterone system inhibitors (RAASi)
|
1329 Participants
n=99 Participants
|
1350 Participants
n=107 Participants
|
2679 Participants
n=206 Participants
|
|
Exposures prior to AKI
(Non-steroidal anti-inflammatory drugs (NSAIDs)
|
805 Participants
n=99 Participants
|
748 Participants
n=107 Participants
|
1553 Participants
n=206 Participants
|
|
Exposures prior to AKI
(Proton pump inhibitors (PPIs)
|
1644 Participants
n=99 Participants
|
1654 Participants
n=107 Participants
|
3298 Participants
n=206 Participants
|
|
Exposures prior to AKI
Patients on one medication of interest (RAASi, NSAID, or PPI)
|
1451 Participants
n=99 Participants
|
1470 Participants
n=107 Participants
|
2921 Participants
n=206 Participants
|
|
Exposures prior to AKI
Patients on two medications of interest (RAASi, NSAID, or PPI)
|
904 Participants
n=99 Participants
|
904 Participants
n=107 Participants
|
1808 Participants
n=206 Participants
|
|
Exposures prior to AKI
Patients on three medications of interest (RAASi, NSAID, or PPI)
|
173 Participants
n=99 Participants
|
158 Participants
n=107 Participants
|
331 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 14 days from RandomizationProgression of AKI is defined by an increase in KDIGO creatinine stage from time of randomization to the present. Dialysis is defined by the receipt of hemodialysis, continuous renal replacement therapy or peritoneal dialysis. Isolated ultrafiltration treatments will not be included. Mortality will be determined from hospital records.
Outcome measures
| Measure |
Usual Care
n=2528 Participants
No alert will be fired.
|
Drug-specific Alert
n=2532 Participants
A drug-specific AKI alert, including information about the drug of interest as well as the presence of AKI will be fired.
Drug-specific alert: A drug-specific alert, informing the provider of the presence of AKI as well as recent exposure to a potentially nephrotoxic agent, will be fired.
|
|---|---|---|
|
Percentage of Patients With Progression of AKI OR Dialysis OR Death
|
639 Participants
|
585 Participants
|
SECONDARY outcome
Timeframe: Assessed within 24 hours from randomizationThe Percentage of patients for whom the targeted agent was discontinued within 24 hours from randomization. For individuals with active orders for more than one targeted agent, cessation of any will be adequate to meet this endpoint.
Outcome measures
| Measure |
Usual Care
n=2528 Participants
No alert will be fired.
|
Drug-specific Alert
n=2532 Participants
A drug-specific AKI alert, including information about the drug of interest as well as the presence of AKI will be fired.
Drug-specific alert: A drug-specific alert, informing the provider of the presence of AKI as well as recent exposure to a potentially nephrotoxic agent, will be fired.
|
|---|---|---|
|
Percentage of Patients for Whom Any One of the Targeted Medications is Discontinued
|
1413 Participants
|
1547 Participants
|
SECONDARY outcome
Timeframe: Assessed from date of randomization to date of death from any cause, within 14 days of randomizationPercentage of patients who expire within 14 days of randomization
Outcome measures
| Measure |
Usual Care
n=2528 Participants
No alert will be fired.
|
Drug-specific Alert
n=2532 Participants
A drug-specific AKI alert, including information about the drug of interest as well as the presence of AKI will be fired.
Drug-specific alert: A drug-specific alert, informing the provider of the presence of AKI as well as recent exposure to a potentially nephrotoxic agent, will be fired.
|
|---|---|---|
|
14- Day Mortality Rate
|
282 Participants
|
253 Participants
|
SECONDARY outcome
Timeframe: Assessed from point of randomization to the date of death from any cause during the end of current index hospitalization, up to 365 daysPercentage of patients who expire during index hospitalization.
Outcome measures
| Measure |
Usual Care
n=2528 Participants
No alert will be fired.
|
Drug-specific Alert
n=2532 Participants
A drug-specific AKI alert, including information about the drug of interest as well as the presence of AKI will be fired.
Drug-specific alert: A drug-specific alert, informing the provider of the presence of AKI as well as recent exposure to a potentially nephrotoxic agent, will be fired.
|
|---|---|---|
|
Inpatient Mortality Rate
|
365 Participants
|
356 Participants
|
SECONDARY outcome
Timeframe: Assessed from point of randomization to date of first documented dialysis order, within 14 days of randomizationReceipt of hemodialysis, continuous renal replacement, or peritoneal dialysis within 14 days of randomization
Outcome measures
| Measure |
Usual Care
n=2528 Participants
No alert will be fired.
|
Drug-specific Alert
n=2532 Participants
A drug-specific AKI alert, including information about the drug of interest as well as the presence of AKI will be fired.
Drug-specific alert: A drug-specific alert, informing the provider of the presence of AKI as well as recent exposure to a potentially nephrotoxic agent, will be fired.
|
|---|---|---|
|
Percentage of Patients Who Receive Dialysis Within 14 Days of Randomization
|
127 Participants
|
123 Participants
|
SECONDARY outcome
Timeframe: Assessed from point of randomization to the date of first documented dialysis order during index hospitalization, up to 365 daysReceipt of hemodialysis, continuous renal replacement, or peritoneal dialysis during index hospitalization
Outcome measures
| Measure |
Usual Care
n=2528 Participants
No alert will be fired.
|
Drug-specific Alert
n=2532 Participants
A drug-specific AKI alert, including information about the drug of interest as well as the presence of AKI will be fired.
Drug-specific alert: A drug-specific alert, informing the provider of the presence of AKI as well as recent exposure to a potentially nephrotoxic agent, will be fired.
|
|---|---|---|
|
Percentage of Patients on Inpatient Dialysis
|
137 Participants
|
151 Participants
|
SECONDARY outcome
Timeframe: Assessed at the point of discharge from index hospitalization, up to 365 days post randomizationActive orders for dialysis at the point of discharge from the index hospitalization
Outcome measures
| Measure |
Usual Care
n=2528 Participants
No alert will be fired.
|
Drug-specific Alert
n=2532 Participants
A drug-specific AKI alert, including information about the drug of interest as well as the presence of AKI will be fired.
Drug-specific alert: A drug-specific alert, informing the provider of the presence of AKI as well as recent exposure to a potentially nephrotoxic agent, will be fired.
|
|---|---|---|
|
Percentage of Patients Discharged on Dialysis
|
105 Participants
|
127 Participants
|
SECONDARY outcome
Timeframe: Assessed from date of randomization to date of documented AKI progression, within 14 days of randomizationPopulation: Population analyzed represents the number of subjects with AKI Stage 1 upon enrollment.
Progression to stage 2 AKI, represented by a doubling of baseline creatinine levels.
Outcome measures
| Measure |
Usual Care
n=2248 Participants
No alert will be fired.
|
Drug-specific Alert
n=2279 Participants
A drug-specific AKI alert, including information about the drug of interest as well as the presence of AKI will be fired.
Drug-specific alert: A drug-specific alert, informing the provider of the presence of AKI as well as recent exposure to a potentially nephrotoxic agent, will be fired.
|
|---|---|---|
|
Percentage of Patients With AKI Progression From Stage 1 to Stage 2
|
248 Participants
|
242 Participants
|
SECONDARY outcome
Timeframe: Assessed from date of randomization to date of documented AKI progression, within 14 days of randomizationPopulation: Analyzed population includes subjects with Stage 1 or Stage 2 AKI upon enrollment.
Progression to stage 3 AKI, represented by a tripling of baseline creatinine levels.
Outcome measures
| Measure |
Usual Care
n=2478 Participants
No alert will be fired.
|
Drug-specific Alert
n=2470 Participants
A drug-specific AKI alert, including information about the drug of interest as well as the presence of AKI will be fired.
Drug-specific alert: A drug-specific alert, informing the provider of the presence of AKI as well as recent exposure to a potentially nephrotoxic agent, will be fired.
|
|---|---|---|
|
Percentage of Patients With AKI Progression From Stage 2 to Stage 3
|
256 Participants
|
231 Participants
|
SECONDARY outcome
Timeframe: Assessed from the point of randomization to the point of AKI cessation during index hospitalization, up to 365 daysTime in hours between AKI onset and AKI cessation during index hospitalization
Outcome measures
| Measure |
Usual Care
n=2528 Participants
No alert will be fired.
|
Drug-specific Alert
n=2532 Participants
A drug-specific AKI alert, including information about the drug of interest as well as the presence of AKI will be fired.
Drug-specific alert: A drug-specific alert, informing the provider of the presence of AKI as well as recent exposure to a potentially nephrotoxic agent, will be fired.
|
|---|---|---|
|
AKI Duration
|
1.1 days
Interval 0.8 to 2.2
|
1 days
Interval 0.8 to 2.1
|
SECONDARY outcome
Timeframe: Within 30 days of index hospitalization dischargeNumber of readmissions within 30 days of discharge from index hospitalization
Outcome measures
| Measure |
Usual Care
n=2528 Participants
No alert will be fired.
|
Drug-specific Alert
n=2532 Participants
A drug-specific AKI alert, including information about the drug of interest as well as the presence of AKI will be fired.
Drug-specific alert: A drug-specific alert, informing the provider of the presence of AKI as well as recent exposure to a potentially nephrotoxic agent, will be fired.
|
|---|---|---|
|
Readmission Rate
|
354 Participants
|
322 Participants
|
SECONDARY outcome
Timeframe: Assessed from point of randomization to the date of discharge from index hospitalization, up to 365 days post randomizationTotal cost of index hospitalization
Outcome measures
| Measure |
Usual Care
n=2528 Participants
No alert will be fired.
|
Drug-specific Alert
n=2532 Participants
A drug-specific AKI alert, including information about the drug of interest as well as the presence of AKI will be fired.
Drug-specific alert: A drug-specific alert, informing the provider of the presence of AKI as well as recent exposure to a potentially nephrotoxic agent, will be fired.
|
|---|---|---|
|
Index Hospitalization Cost
|
27900 dollars
Interval 12500.0 to 63400.0
|
26900 dollars
Interval 12400.0 to 63600.0
|
SECONDARY outcome
Timeframe: Assessed from 24 hours from randomization up to discharge of index hospitalizationBest practices assessed include: Avoidance of nephrotoxins (cessation of order or absence of de novo order of IV constrast agent, aminoglycoside, NSAID, or ACE inhibitor within 24 hours of randomization), fluid administration (administration of fluids within 24 hours of randomization), 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 occurring within 36 hours of randomization), documentation of urine output (within 24 hours of randomization), renal consult order during index hospitalization. Each metric above is binary. Outcome is reported as a composite best practice outcome representing the proportion of best practices achieved per subject.
Outcome measures
| Measure |
Usual Care
n=2528 Participants
No alert will be fired.
|
Drug-specific Alert
n=2532 Participants
A drug-specific AKI alert, including information about the drug of interest as well as the presence of AKI will be fired.
Drug-specific alert: A drug-specific alert, informing the provider of the presence of AKI as well as recent exposure to a potentially nephrotoxic agent, will be fired.
|
|---|---|---|
|
Percentage of AKI "Best Practices" Achieved Per Subject During Index Hospitalization
Contrast administration
|
502 Participants
|
519 Participants
|
|
Percentage of AKI "Best Practices" Achieved Per Subject During Index Hospitalization
Fluid administration
|
1572 Participants
|
1537 Participants
|
|
Percentage of AKI "Best Practices" Achieved Per Subject During Index Hospitalization
Aminoglycoside administration
|
20 Participants
|
18 Participants
|
|
Percentage of AKI "Best Practices" Achieved Per Subject During Index Hospitalization
NSAID administration
|
264 Participants
|
245 Participants
|
|
Percentage of AKI "Best Practices" Achieved Per Subject During Index Hospitalization
ACEi administration
|
377 Participants
|
316 Participants
|
|
Percentage of AKI "Best Practices" Achieved Per Subject During Index Hospitalization
Urinalysis order
|
1013 Participants
|
1024 Participants
|
|
Percentage of AKI "Best Practices" Achieved Per Subject During Index Hospitalization
Documentation of AKI
|
956 Participants
|
1000 Participants
|
|
Percentage of AKI "Best Practices" Achieved Per Subject During Index Hospitalization
Monitoring of creatinine
|
2325 Participants
|
2331 Participants
|
|
Percentage of AKI "Best Practices" Achieved Per Subject During Index Hospitalization
Monitoring of urine output
|
2085 Participants
|
2104 Participants
|
|
Percentage of AKI "Best Practices" Achieved Per Subject During Index Hospitalization
Renal consult
|
392 Participants
|
393 Participants
|
SECONDARY outcome
Timeframe: Assessed from time of randomization through to date of index hospitalization discharge, up to 365 days post randomizationPercentage of subjects with chart documentation of AKI by post-discharge ICD-10 codes and by chart adjudication
Outcome measures
| Measure |
Usual Care
n=2528 Participants
No alert will be fired.
|
Drug-specific Alert
n=2532 Participants
A drug-specific AKI alert, including information about the drug of interest as well as the presence of AKI will be fired.
Drug-specific alert: A drug-specific alert, informing the provider of the presence of AKI as well as recent exposure to a potentially nephrotoxic agent, will be fired.
|
|---|---|---|
|
Percentage of Subjects With Chart Documentation of AKI
|
956 Participants
|
1000 Participants
|
Adverse Events
Usual Care
Drug-specific Alert
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