N/A
N=5,060
Drug-Targeted Alerts for Acute Kidney Injury
Acute Kidney Injury
Bottom Line
View on ClinicalTrials.gov: NCT02771977 ↗Enrolled (actual)
5,060
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Percentage of Patients With Progression of AKI OR Dialysis OR Death — 639; 585 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Drug-specific alert (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Progression of AKI OR Dialysis OR Death |
639; 585 | — |
| SECONDARY Percentage of Patients for Whom Any One of the Targeted Medications is Discontinued |
1413; 1547 | — |
| SECONDARY 14- Day Mortality Rate |
282; 253 | — |
| SECONDARY Inpatient Mortality Rate |
365; 356 | — |
| SECONDARY Percentage of Patients Who Receive Dialysis Within 14 Days of Randomization |
127; 123 | — |
| SECONDARY Percentage of Patients on Inpatient Dialysis |
137; 151 | — |
| SECONDARY Percentage of Patients Discharged on Dialysis |
105; 127 | — |
| SECONDARY Percentage of Patients With AKI Progression From Stage 1 to Stage 2 |
248; 242 | — |
| SECONDARY Percentage of Patients With AKI Progression From Stage 2 to Stage 3 |
256; 231 | — |
| SECONDARY AKI Duration |
1.1; 1 | — |
| SECONDARY Readmission Rate |
354; 322 | — |
| SECONDARY Index Hospitalization Cost |
27900; 26900 | — |
| SECONDARY Percentage of AKI "Best Practices" Achieved Per Subject During Index Hospitalization |
502; 519; 1572; 1537; 20; 18 | — |
| SECONDARY Percentage of Subjects With Chart Documentation of AKI |
956; 1000 | — |
Summary
In this trial, patients with acute kidney injury who have recently received a drug that may affect kidney function will be randomized to having an alert placed in the electronic health record or usual care.
Eligibility Criteria
Inclusion Criteria
- Acute Kidney Injury based upon the Kidney Disease: Improving Global Outcomes creatinine criteria (a 0.3mg/dl increase over 48 hours or 50% increase over 7 days) and an active order within the past 24 hours to one of the following classes of medications:
- Non-steroidal anti-inflammatory drug
- Renin Angiotensin Aldosterone System Antagonists
- Proton Pump Inhibitors
Exclusion Criteria
- Dialysis order prior to AKI onset
- Previous randomization
- Admission to a hospice service or CMO
- First hospital creatinine >=4.0 mg/dl
- ESKD diagnosis code
- Kidney transplant within six months prior to randomization
Data sourced from ClinicalTrials.gov (NCT02771977). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.