Acute Kidney Injury
Conditions
Brief summary
This study will randomize hospitalized patients with acute kidney injury (AKI) to usual care, or an electronic alert intervention. The electronic alert will be in the form of a text page that will be sent to the covering clinician and unit pharmacist once per patient with AKI at the time lab results are uploaded. The investigators hypothesize that such an alert will improve outcomes in these patients.
Interventions
OTHERAlert
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults \>=18 years * Admitted to the Hospital of the University of Pennsylvania for greater than 24 hours.
Exclusion criteria
* Dialysis order within 24 hours of admission * Dialysis order prior to AKI onset * Initial creatinine \>=4.0mg/dl * Prior admission in which patient was randomized. * Nephrectomy during the admission * Admission to hospice service * Admission to observation status
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dialysis Within 7 Days | From start of AKI to 7 days later | This metric will be sequentially ranked. The provision of acute dialysis therapy will be ranked as a more severe outcome than the worst relative change in creatinine and death will be ranked as a more severe outcome than dialysis. |
| Death | 7 days of randomization | — |
| Relative Maximum Change in Creatinine | 7 days of randomization | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Alert Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine. | 1,201 |
| Usual Care Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist. | 1,192 |
| Total | 2,393 |
Baseline characteristics
| Characteristic | Usual Care | Alert | Total |
|---|---|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 16 | 60 years STANDARD_DEVIATION 17 | 60 years STANDARD_DEVIATION 16 |
| Baseline Creatinine | 0.90 mg/dl | 0.91 mg/dl | 0.90 mg/dl |
| Diabetes | 370 participants | 352 participants | 722 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 38 Participants | 33 Participants | 71 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1154 Participants | 1168 Participants | 2322 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Asian | 30 Participants | 15 Participants | 45 Participants |
| Race (NIH/OMB) Black or African American | 323 Participants | 324 Participants | 647 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 159 Participants | 170 Participants | 329 Participants |
| Race (NIH/OMB) White | 675 Participants | 689 Participants | 1364 Participants |
| Sex: Female, Male Female | 537 Participants | 531 Participants | 1068 Participants |
| Sex: Female, Male Male | 655 Participants | 670 Participants | 1325 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1,201 | 0 / 1,192 |
| serious Total, serious adverse events | 0 / 1,201 | 0 / 1,192 |
Outcome results
Primary
Death
Time frame: 7 days of randomization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alert | Death | 71 participants |
| Usual Care | Death | 61 participants |
Primary
Dialysis Within 7 Days
This metric will be sequentially ranked. The provision of acute dialysis therapy will be ranked as a more severe outcome than the worst relative change in creatinine and death will be ranked as a more severe outcome than dialysis.
Time frame: From start of AKI to 7 days later
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alert | Dialysis Within 7 Days | 87 participants |
| Usual Care | Dialysis Within 7 Days | 70 participants |
Primary
Relative Maximum Change in Creatinine
Time frame: 7 days of randomization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Alert | Relative Maximum Change in Creatinine | 0.0 relative percent change |
| Usual Care | Relative Maximum Change in Creatinine | 0.6 relative percent change |