Trial Outcomes & Findings for Achieving Medication Safety During Acute Kidney Injury (NCT NCT01134900)
NCT ID: NCT01134900
Last Updated: 2012-02-27
Results Overview
Our primary outcome measured the rate of AKI-related ADEs and pADEs. We defined pADEs as incidents with the potential for injury related to a drug, such as use of a non-steroidal anti-inflammatory drug for at least 24 hours, and ADEs as injuries resulting from the administration of a drug, such as a toxic vancomycin trough level or a bleed after administration of enoxaparin. We measured outcomes after completion of the inpatient encounter (either by death or discharge); pADEs or ADEs occurring after patient discharge were not included in the analysis.
COMPLETED
NA
540 participants
Until patient discharge (~2 week average)
2012-02-27
Participant Flow
We performed a randomized, controlled trial during June 1, 2010 through August 31, 2010 at a large academic, tertiary care facility. We included all admitted adult patients who experienced a 0.5 mg/dl change in serum creatinine over 48 hours following an active, recurring order for one or more targeted nephrotoxic or renally cleared medications.
Patients who were dialyzed prior to the first serum creatinine change event or identified as a dialysis patient through a dialysis flag order, in addition to those admitted to renal transplant, liver transplant, or nephrology services were excluded.
Participant milestones
| Measure |
Dashboard
Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
|
Control
Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
|
|---|---|---|
|
Overall Study
STARTED
|
200
|
196
|
|
Overall Study
COMPLETED
|
200
|
196
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Achieving Medication Safety During Acute Kidney Injury
Baseline characteristics by cohort
| Measure |
Dashboard
n=200 Participants
Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
|
Control
n=196 Participants
Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
|
Total
n=396 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
111 Participants
n=99 Participants
|
120 Participants
n=107 Participants
|
231 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
89 Participants
n=99 Participants
|
76 Participants
n=107 Participants
|
165 Participants
n=206 Participants
|
|
Age Continuous
|
60.7 years
STANDARD_DEVIATION 16.8 • n=99 Participants
|
58.3 years
STANDARD_DEVIATION 15.7 • n=107 Participants
|
59.5 years
STANDARD_DEVIATION 16.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
171 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=99 Participants
|
119 Participants
n=107 Participants
|
225 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
200 participants
n=99 Participants
|
196 participants
n=107 Participants
|
396 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Until patient discharge (~2 week average)Our primary outcome measured the rate of AKI-related ADEs and pADEs. We defined pADEs as incidents with the potential for injury related to a drug, such as use of a non-steroidal anti-inflammatory drug for at least 24 hours, and ADEs as injuries resulting from the administration of a drug, such as a toxic vancomycin trough level or a bleed after administration of enoxaparin. We measured outcomes after completion of the inpatient encounter (either by death or discharge); pADEs or ADEs occurring after patient discharge were not included in the analysis.
Outcome measures
| Measure |
Dashboard
n=1396 Patient-Medication Pairs
Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
|
Control
n=1303 Patient-Medication Pairs
Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
|
|---|---|---|
|
Adverse Drug Events or Potential Adverse Drug Events
|
99 Patient-Medication Pairs
|
104 Patient-Medication Pairs
|
SECONDARY outcome
Timeframe: Until patient discharge (~2 week average)Time from study event to modification or discontinuation of targeted medication
Outcome measures
| Measure |
Dashboard
n=1396 Patient-Medication Pairs
Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
|
Control
n=1303 Patient-Medication Pairs
Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
|
|---|---|---|
|
Time to Provider Response
Ordered Prior to AKI
|
23.7 Hours
Interval 5.61 to 57.67
|
27.31 Hours
Interval 5.98 to 62.57
|
|
Time to Provider Response
Ordered After AKI
|
42.37 Hours
Interval 17.9 to 77.93
|
43.83 Hours
Interval 17.62 to 80.58
|
Adverse Events
Dashboard
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Allison B. McCoy, PhD
The University of Texas Health Science Center at Houston (UTHealth)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place