Trial Outcomes & Findings for An Electronic Alert System for In-Hospital Acute Kidney Injury (NCT NCT01862419)
NCT ID: NCT01862419
Last Updated: 2015-03-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2393 participants
Primary outcome timeframe
From start of AKI to 7 days later
Results posted on
2015-03-25
Participant Flow
Participant milestones
| Measure |
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.
|
Usual Care
Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
|
|---|---|---|
|
Overall Study
STARTED
|
1201
|
1192
|
|
Overall Study
COMPLETED
|
1201
|
1192
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Electronic Alert System for In-Hospital Acute Kidney Injury
Baseline characteristics by cohort
| Measure |
Alert
n=1201 Participants
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.
|
Usual Care
n=1192 Participants
Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
|
Total
n=2393 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 17 • n=99 Participants
|
61 years
STANDARD_DEVIATION 16 • n=107 Participants
|
60 years
STANDARD_DEVIATION 16 • n=206 Participants
|
|
Sex: Female, Male
Female
|
531 Participants
n=99 Participants
|
537 Participants
n=107 Participants
|
1068 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
670 Participants
n=99 Participants
|
655 Participants
n=107 Participants
|
1325 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
33 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1168 Participants
n=99 Participants
|
1154 Participants
n=107 Participants
|
2322 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
324 Participants
n=99 Participants
|
323 Participants
n=107 Participants
|
647 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
689 Participants
n=99 Participants
|
675 Participants
n=107 Participants
|
1364 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
170 Participants
n=99 Participants
|
159 Participants
n=107 Participants
|
329 Participants
n=206 Participants
|
|
Baseline Creatinine
|
0.91 mg/dl
n=99 Participants
|
0.90 mg/dl
n=107 Participants
|
0.90 mg/dl
n=206 Participants
|
|
Diabetes
|
352 participants
n=99 Participants
|
370 participants
n=107 Participants
|
722 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From start of AKI to 7 days laterThis 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.
Outcome measures
| Measure |
Alert
n=1201 Participants
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.
|
Usual Care
n=1192 Participants
Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
|
|---|---|---|
|
Dialysis Within 7 Days
|
87 participants
|
70 participants
|
PRIMARY outcome
Timeframe: 7 days of randomizationOutcome measures
| Measure |
Alert
n=1201 Participants
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.
|
Usual Care
n=1192 Participants
Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
|
|---|---|---|
|
Death
|
71 participants
|
61 participants
|
PRIMARY outcome
Timeframe: 7 days of randomizationOutcome measures
| Measure |
Alert
n=1201 Participants
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.
|
Usual Care
n=1192 Participants
Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
|
|---|---|---|
|
Relative Maximum Change in Creatinine
|
0.0 relative percent change
Interval 0.0 to 18.4
|
0.6 relative percent change
Interval 0.0 to 17.5
|
Adverse Events
Alert
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Francis Perry Wilson, MD MSCE
Yale University School of Medicine
Phone: 2037371704
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place