An interventional study of AKI Alert in Acute Kidney Injury, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-10.
Sponsored by Yale University · Not applicable, Interventional, and Supportive care
This study will enroll hospitalized adults with acute kidney injury (AKI) and randomize them to usual care versus an electronic alert coupled to a "best practices" order set.
Acute kidney injury (AKI) carries a significant, independent risk of mortality among hospitalized patients. Recent studies have demonstrated increased mortality among patients with even small increases in serum creatinine concentration. International guidelines for the treatment of AKI focus on appropriate management of drug dosing, avoiding nephrotoxic exposures, and careful attention to fluid and electrolyte balance. Early nephrologist involvement may also improve outcomes in AKI. Without appropriate provider recognition of AKI, however, none of these measures can be taken, and patient outcomes may suffer. AKI is frequently overlooked by clinicians, but carries a substantial cost, morbidity and mortality burden.
The investigators conducted a pilot, randomized trial of electronic alerts for acute kidney injury in 2014. The trial, which randomized 2400 patients with AKI as defined by an increase in creatinine of 0.3mg/dl over 48 hours or 50% over 7 days, found that alerting physicians to the presence of AKI did not improve the course of acute kidney injury, reduce dialysis or death rates. However this study was conducted in a single hospital, and the alert itself did not describe specific actions that a provider could take. In the present proposal, the investigators seek to expand upon their prior study to determine both the modes of alerting that would be most effective and to determine if targeting alerts (such as to patients on medications that may worsen acute kidney injury) will improve effectiveness.
This study will be a randomized, controlled trial of an electronic AKI alert system. Using the Kidney Disease: Improve Global Outcomes creatinine criteria, inpatients at several hospitals will be randomized to usual care versus electronic alerting. The primary outcome will be a composite of progression of acute kidney injury, dialysis and death.
1,641 studies on the registry are indexed under Acute Kidney Injury; 380 are open to participants now.
This study's enrollment of 6,030 is above the median of 100 across 786 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Yale University is the lead sponsor of 1,763 studies on the registry; 292 are open to participants now.
Of its 217 completed or terminated interventional studies of FDA-regulated products, 128 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
No alert will be fired.
A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves.
Other: AKI Alert
Provider's will receive a "pop-up" alert in the electronic health record until AKI is documented in the problem list or AKI resolves.
Composite of 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.
Time frame: 14 days from randomization
Mortality
14-day or inpatient mortality
Time frame: 14 days from randomization
Dialysis
14-day, inpatient, or discharged on dialysis
Time frame: 14 days from randomization
AKI Progression
Percent of patients who progress to stage 2 AKI and to stage 3 AKI
Time frame: 14 days from randomization
AKI Duration
Number of participants with AKI duration of \<2 days, 2-\<days, and 7+ days (Aki duration defined as time in days between AKI onset and AKI cessation during index hospitalization)
Time frame: 14 days from randomization
Readmission Rate
30 day readmission rate
Time frame: 30 days from randomization
Index Hospitalization Cost
Cost of index hospitalization, measured in direct and total costs. Direct costs reflect those associated with direct patient contact involving billable services (for example lab, nursing costs, and supplies). Total costs also include non-billable support services such as medical records, human resources, accounting, support staff, utilities and dietary costs.
Time frame: Index hospitalization through discharge, up to one year
Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization
Best practices assessed include: Avoidance of nephrotoxins (cessation of order or absence of de novo order of IV contrast 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.
Time frame: 24 hours from randomization to discharge, up to one year
Number of Subjects With Chart Documentation of AKI
Proportion of subjects with chart documentation of AKI by post-discharge ICD-10 codes and by chart adjudication
Time frame: Index hospitalization
From 3/29/2018 to 12/14/2019, 6,030 individuals met enrollment criteria and were randomized across 6 hospitals of a single healthcare system.
| Milestone | Usual Care | Electronic AKI Alert |
|---|---|---|
| Started | 2971 | 3059 |
| Completed | 2971 | 3059 |
| Not completed | 0 | 0 |
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.
| Participants | Usual Care | Electronic AKI Alert |
|---|---|---|
| Composite of Progression of AKI, Inpatient Dialysis, or Inpatient Death | 622 | 653 |
14-day or inpatient mortality
| Participants | Usual Care | Electronic AKI Alert |
|---|---|---|
| Mortality | 265 | 272 |
14-day, inpatient, or discharged on dialysis
| Participants | Usual Care | Electronic AKI Alert |
|---|---|---|
| Dialysis | 93 | 106 |
Percent of patients who progress to stage 2 AKI and to stage 3 AKI
| Participants | Usual Care | Electronic AKI Alert |
|---|---|---|
| AKI Progression | 461 | 487 |
Number of participants with AKI duration of \<2 days, 2-\<days, and 7+ days (Aki duration defined as time in days between AKI onset and AKI cessation during index hospitalization)
| Participants | Usual Care | Electronic AKI Alert |
|---|---|---|
| <2 days | 2108 | 2239 |
| 2-<7 days | 722 | 700 |
| 7+ days | 141 | 120 |
30 day readmission rate
No measurements were reported for this outcome.
Cost of index hospitalization, measured in direct and total costs. Direct costs reflect those associated with direct patient contact involving billable services (for example lab, nursing costs, and supplies). Total costs also include non-billable support services such as medical records, human resources, accounting, support staff, utilities and dietary costs.
| dollars | Usual Care | Electronic AKI Alert |
|---|---|---|
| Direct Costs | 10300 (5400 to 21900) | 10600 (5400 to 22800) |
| Total Costs | 19100 (9900 to 42500) | 20100 (10200 to 43600) |
Best practices assessed include: Avoidance of nephrotoxins (cessation of order or absence of de novo order of IV contrast 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.
| Participants | Usual Care | Electronic AKI Alert |
|---|---|---|
| IV fluid drip order | 1034 | 1174 |
| IV fluid bolus order | 339 | 397 |
| Urinalysis | 444 | 519 |
| Urine Output Measurement | 2130 | 2242 |
| Subsequent Creatinine Measurement (28 hours) | 2532 | 2666 |
| Renal Consult (within 14 days) | 517 | 541 |
| Contrast exposure | 102 | 115 |
| Aminoglycoside exposure | 19 | 14 |
| Aminoglycoside exposure among those already receiving aminoglycoside | 8 | 5 |
| NSAID exposure | 166 | 144 |
| NSAID exposure among those already receiving NSAIDs | 129 | 103 |
| ACE/ARB exposure | 425 | 424 |
| ACE/ARB exposure among those already receiving ACE/ARB | 326 | 331 |
| AKI documentation (at end of encounter) | 1871 | 2141 |
Proportion of subjects with chart documentation of AKI by post-discharge ICD-10 codes and by chart adjudication
| Participants | Usual Care | Electronic AKI Alert |
|---|---|---|
| Number of Subjects With Chart Documentation of AKI | 1871 | 2141 |
Collected over Duration of the study (22 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual Care | 265/2,971 (8.9%) | 0/2,971 (0%) | 0/2,971 (0%) |
| Electronic AKI Alert | 272/3,059 (8.9%) | 0/3,059 (0%) | 0/3,059 (0%) |
| Age, Continuous(years) | Usual Care | Electronic AKI Alert | Total |
|---|---|---|---|
| Median | 71.3 (59.4 to 81.6) | 71 (59 to 81.7) | 71.2 (59.2 to 81.7) |
| Sex: Female, Male(Participants) | Usual Care | Electronic AKI Alert | Total |
|---|---|---|---|
| Female | 1440 | 1442 | 2882 |
| Male | 1531 | 1617 | 3148 |
| Ethnicity (NIH/OMB)(Participants) | Usual Care | Electronic AKI Alert | Total |
|---|---|---|---|
| Hispanic or Latino | 289 | 331 | 620 |
| Not Hispanic or Latino | 2664 | 2712 | 5376 |
| Unknown or Not Reported | 18 | 16 | 34 |
| Race (NIH/OMB)(Participants) | Usual Care | Electronic AKI Alert | Total |
|---|---|---|---|
| American Indian or Alaska Native | 6 | 8 | 14 |
| Asian | 35 | 40 | 75 |
| Native Hawaiian or Other Pacific Islander | 4 | 3 | 7 |
| Black or African American | 462 | 484 | 946 |
| White | 2208 | 2234 | 4442 |
| More than one race | NA | NA | NA |
| Unknown or Not Reported | 19 | 23 | 42 |
| Region of Enrollment(participants) | Usual Care | Electronic AKI Alert | Total |
|---|---|---|---|
| United States | 2971 | 3059 | 6030 |
| Medical Admission(Participants) | Usual Care | Electronic AKI Alert | Total |
|---|---|---|---|
| Count of participants | 2280 | 2284 | 4564 |
| ICU Patient(Participants) | Usual Care | Electronic AKI Alert | Total |
|---|---|---|---|
| Count of participants | 961 | 962 | 1923 |
| ER Patient(Participants) | Usual Care | Electronic AKI Alert | Total |
|---|---|---|---|
| Count of participants | 108 | 93 | 201 |
35 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified aggregate data for the primary and secondary outcomes will be made available.
Supporting information: Study protocol
Time frame: Data will be available within one year of completion.
Ran from Mar 2018 to primary completion in Jan 2020, 21 months.
Results were first posted in Feb 2022, 2 years 1 month after primary completion.
Of 239 non-industry interventional studies with no phase under Acute Kidney Injury, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 44. This study's 21 months is below that.
Counting every sponsor, half of 255 studies reached it within 26 months; a quarter within 12 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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