Trial Outcomes & Findings for Acute Kidney Injury in Patients Undergoing Contrast Exposure: VQ vs. CT (NCT NCT03116139)
NCT ID: NCT03116139
Last Updated: 2026-03-23
Results Overview
Count of participants with a creatinine increase ≥ 0.3 mg/dL or 1.5 times baseline.
TERMINATED
NA
253 participants
7 days post enrollment
2026-03-23
Participant Flow
Participant milestones
| Measure |
Randomized to V/Q
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control)
V/Q imaging: Standard of care
|
Randomized to CT
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media)
Computed tomography scan: Standard of care
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
180
|
|
Overall Study
COMPLETED
|
60
|
161
|
|
Overall Study
NOT COMPLETED
|
13
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acute Kidney Injury in Patients Undergoing Contrast Exposure: VQ vs. CT
Baseline characteristics by cohort
| Measure |
Randomized to V/Q
n=73 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control)
V/Q imaging: Standard of care
|
Randomized to CT
n=180 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media)
Computed tomography scan: Standard of care
|
Total
n=253 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=10 Participants
|
137 Participants
n=8 Participants
|
179 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
31 Participants
n=10 Participants
|
43 Participants
n=8 Participants
|
74 Participants
n=18 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=10 Participants
|
103 Participants
n=8 Participants
|
143 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=10 Participants
|
77 Participants
n=8 Participants
|
110 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=10 Participants
|
82 Participants
n=8 Participants
|
109 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=10 Participants
|
91 Participants
n=8 Participants
|
137 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: 7 days post enrollmentCount of participants with a creatinine increase ≥ 0.3 mg/dL or 1.5 times baseline.
Outcome measures
| Measure |
Randomized to V/Q
n=73 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control)
V/Q imaging: Standard of care
|
Randomized to CT
n=180 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media)
Computed tomography scan: Standard of care
|
|---|---|---|
|
Count of Participants Who Developed AKI at 7 Days
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 30 days after enrollmentCount of participants with a creatinine increase ≥ 0.3 mg/dL or 1.5 times baseline
Outcome measures
| Measure |
Randomized to V/Q
n=73 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control)
V/Q imaging: Standard of care
|
Randomized to CT
n=180 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media)
Computed tomography scan: Standard of care
|
|---|---|---|
|
Count of Participants Who Developed AKI at 30 Day Follow-up
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 1 year after enrollmentCount of participants with a creatinine increase ≥ 0.3 mg/dL or 1.5 times baseline
Outcome measures
| Measure |
Randomized to V/Q
n=60 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control)
V/Q imaging: Standard of care
|
Randomized to CT
n=161 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media)
Computed tomography scan: Standard of care
|
|---|---|---|
|
Count of Participants Who Developed AKI at 1 Year Follow-up
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Within 7 days of enrollmentPopulation: Analysis restricted to participants with an AKI Score ≥2 and those who were followed for the designated duration. There were 56 participants with an AKI Score ≥2 in the V/Q arm and 63 in the CT arm.
Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6.
Outcome measures
| Measure |
Randomized to V/Q
n=56 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control)
V/Q imaging: Standard of care
|
Randomized to CT
n=63 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media)
Computed tomography scan: Standard of care
|
|---|---|---|
|
Count of Participants With an AKI Risk Score ≥2, That Developed AKI Within 7 Days
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Within 30 days of enrollmentPopulation: Analysis restricted to participants with an AKI Score ≥2 and those who were followed for the designated duration. There were 56 participants with an AKI Score ≥2 in the V/Q arm and 63 in the CT arm.
Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6.
Outcome measures
| Measure |
Randomized to V/Q
n=56 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control)
V/Q imaging: Standard of care
|
Randomized to CT
n=63 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media)
Computed tomography scan: Standard of care
|
|---|---|---|
|
Count of Participants With an AKI Risk Score ≥2, That Developed AKI Within 30 Days
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Within 1 year of enrollmentPopulation: Analysis restricted to participants with an AKI Score ≥2 and those who were followed for the designated duration. There were 46 participants with an AKI Score ≥2 in the V/Q arm and 49 in the CT arm.
Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6.
Outcome measures
| Measure |
Randomized to V/Q
n=46 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control)
V/Q imaging: Standard of care
|
Randomized to CT
n=49 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media)
Computed tomography scan: Standard of care
|
|---|---|---|
|
Count of Participants With an AKI Risk Score ≥2, That Developed AKI Within 1 Year
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Within 7 days of enrollmentPopulation: Analysis restricted to participants with an AKI Score\<2 and those who were followed for the designated duration. There were 17 participants with an AKI Score \<2 in the V/Q arm and 117 in the CT arm.
Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6.
Outcome measures
| Measure |
Randomized to V/Q
n=17 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control)
V/Q imaging: Standard of care
|
Randomized to CT
n=117 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media)
Computed tomography scan: Standard of care
|
|---|---|---|
|
Count of Participants With an AKI Risk Score <2, That Developed AKI Within 7 Days
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Within 30 days of enrollmentPopulation: Analysis restricted to participants with an AKI Score\<2 and those who were followed for the designated duration. There were 17 participants with an AKI Score \<2 in the V/Q arm and 117 in the CT arm.
Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6.
Outcome measures
| Measure |
Randomized to V/Q
n=17 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control)
V/Q imaging: Standard of care
|
Randomized to CT
n=117 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media)
Computed tomography scan: Standard of care
|
|---|---|---|
|
Count of Participants With an AKI Risk Score <2, That Developed AKI Within 30 Days
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Within 1 year of enrollmentPopulation: Analysis restricted to participants with an AKI Score\<2 and those who were followed for the designated duration. There were 14 participants with an AKI Score \<2 in the V/Q arm and 112 in the CT arm.
Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6.
Outcome measures
| Measure |
Randomized to V/Q
n=14 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control)
V/Q imaging: Standard of care
|
Randomized to CT
n=112 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media)
Computed tomography scan: Standard of care
|
|---|---|---|
|
Count of Participants With an AKI Risk Score <2, That Developed AKI Within 1 Year
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Within 7 days of enrollmentPopulation: Biomarkers not assessed. Samples were not available to test due to a shipping error during which some samples were thawed and a -80 degree freezer failure.
Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 30 days of enrollmentPopulation: Biomarkers not assessed. Samples were not available to test due to a shipping error during which some samples were thawed and a -80 degree freezer failure.
Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 1 year of enrollmentPopulation: Biomarkers not assessed. Samples were not available to test due to a shipping error during which some samples were thawed and a -80 degree freezer failure.
Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 7 days of enrollmentPopulation: Biomarkers not assessed. Samples were not available to test due to a shipping error during which some samples were thawed and a -80 degree freezer failure.
Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 30 days of enrollmentPopulation: Biomarkers not assessed. Samples were not available to test due to a shipping error during which some samples were thawed and a -80 degree freezer failure.
Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 1 year of enrollmentPopulation: Biomarkers not assessed. Samples were not available to test due to a shipping error during which some samples were thawed and a -80 degree freezer failure.
Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 7 days of enrollmentPopulation: Analysis restricted to participants who developed AKI within 7 days. There were 6 participants in the V/Q arm and 6 in the CT arm.
Count of participants who developed AKI within 7 days and had a health outcome. Health outcomes are defined as death, severe kidney injury (AKIN3), or the need for dialysis.
Outcome measures
| Measure |
Randomized to V/Q
n=6 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control)
V/Q imaging: Standard of care
|
Randomized to CT
n=6 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media)
Computed tomography scan: Standard of care
|
|---|---|---|
|
Count of Participants Who Developed AKI Within 7 Days and Had a Health Outcome
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days of enrollmentPopulation: Analysis restricted to participants who did not develop AKI within 7 days. There were 67 participants in the V/Q arm and 174 in the CT arm.
Count of participants who did not develop AKI within 7 days and had a health outcome
Outcome measures
| Measure |
Randomized to V/Q
n=67 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control)
V/Q imaging: Standard of care
|
Randomized to CT
n=174 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media)
Computed tomography scan: Standard of care
|
|---|---|---|
|
Count of Participants Who Did Not Develop AKI Within 7 Days and Had a Health Outcome
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At enrollmentCount of participants with Venous Thromboembolism (VTE) identified on imaging at enrollment
Outcome measures
| Measure |
Randomized to V/Q
n=73 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control)
V/Q imaging: Standard of care
|
Randomized to CT
n=180 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media)
Computed tomography scan: Standard of care
|
|---|---|---|
|
Count of Participants With Venous Thromboembolism (VTE) Identified on Imaging at Enrollment
|
3 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Within 7 days of enrollmentCount of participants with Venous Thromboembolism (VTE) identified on imaging within 7 days of enrollment
Outcome measures
| Measure |
Randomized to V/Q
n=73 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control)
V/Q imaging: Standard of care
|
Randomized to CT
n=180 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media)
Computed tomography scan: Standard of care
|
|---|---|---|
|
Count of Participants With Venous Thromboembolism (VTE) Identified on Imaging Within 7 Days of Enrollment
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 30 days of enrollmentCount of participants with Venous Thromboembolism (VTE) identified on imaging within 30 days of enrollment
Outcome measures
| Measure |
Randomized to V/Q
n=73 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control)
V/Q imaging: Standard of care
|
Randomized to CT
n=180 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media)
Computed tomography scan: Standard of care
|
|---|---|---|
|
Count of Participants With Venous Thromboembolism (VTE) Identified on Imaging Within 30 Days of Enrollment
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 1 year of enrollmentCount of participants with Venous Thromboembolism (VTE) identified on imaging within 1 year of enrollment
Outcome measures
| Measure |
Randomized to V/Q
n=60 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control)
V/Q imaging: Standard of care
|
Randomized to CT
n=161 Participants
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media)
Computed tomography scan: Standard of care
|
|---|---|---|
|
Count of Participants With Venous Thromboembolism (VTE) Identified on Imaging Within 1 Year of Enrollment
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 1 year of enrollmentPopulation: Analysis restricted to participants with VTE identified on imaging within 1 year on enrollment. There were 0 participants in the VQ arm and 0 participants in the CT arm.
Count of participants with Venous Thromboembolism (VTE) that had a health outcome
Outcome measures
Outcome data not reported
Adverse Events
Randomized to V/Q
Randomized to CT
Serious adverse events
| Measure |
Randomized to V/Q
n=73 participants at risk
patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control)
V/Q imaging: Standard of care
|
Randomized to CT
n=180 participants at risk
patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media)
Computed tomography scan: Standard of care
|
|---|---|---|
|
General disorders
Hospitalization
|
26.0%
19/73 • Number of events 58 • Adverse event data were collected at 24 hours, 2-7 days, 30 days, and 1 year after enrollment.
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definition.
|
20.0%
36/180 • Number of events 79 • Adverse event data were collected at 24 hours, 2-7 days, 30 days, and 1 year after enrollment.
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definition.
|
|
General disorders
Death
|
4.1%
3/73 • Number of events 3 • Adverse event data were collected at 24 hours, 2-7 days, 30 days, and 1 year after enrollment.
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definition.
|
0.56%
1/180 • Number of events 1 • Adverse event data were collected at 24 hours, 2-7 days, 30 days, and 1 year after enrollment.
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definition.
|
|
Renal and urinary disorders
AKI
|
8.2%
6/73 • Number of events 6 • Adverse event data were collected at 24 hours, 2-7 days, 30 days, and 1 year after enrollment.
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definition.
|
3.3%
6/180 • Number of events 6 • Adverse event data were collected at 24 hours, 2-7 days, 30 days, and 1 year after enrollment.
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definition.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/73 • Adverse event data were collected at 24 hours, 2-7 days, 30 days, and 1 year after enrollment.
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definition.
|
1.1%
2/180 • Number of events 2 • Adverse event data were collected at 24 hours, 2-7 days, 30 days, and 1 year after enrollment.
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definition.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/73 • Adverse event data were collected at 24 hours, 2-7 days, 30 days, and 1 year after enrollment.
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definition.
|
0.56%
1/180 • Number of events 1 • Adverse event data were collected at 24 hours, 2-7 days, 30 days, and 1 year after enrollment.
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definition.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.4%
1/73 • Number of events 1 • Adverse event data were collected at 24 hours, 2-7 days, 30 days, and 1 year after enrollment.
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definition.
|
0.00%
0/180 • Adverse event data were collected at 24 hours, 2-7 days, 30 days, and 1 year after enrollment.
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definition.
|
|
General disorders
Anaphylaxis type reaction
|
0.00%
0/73 • Adverse event data were collected at 24 hours, 2-7 days, 30 days, and 1 year after enrollment.
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definition.
|
0.00%
0/180 • Adverse event data were collected at 24 hours, 2-7 days, 30 days, and 1 year after enrollment.
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definition.
|
|
Cardiac disorders
NSTEMI
|
1.4%
1/73 • Number of events 1 • Adverse event data were collected at 24 hours, 2-7 days, 30 days, and 1 year after enrollment.
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definition.
|
0.00%
0/180 • Adverse event data were collected at 24 hours, 2-7 days, 30 days, and 1 year after enrollment.
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definition.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/73 • Adverse event data were collected at 24 hours, 2-7 days, 30 days, and 1 year after enrollment.
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definition.
|
0.56%
1/180 • Number of events 1 • Adverse event data were collected at 24 hours, 2-7 days, 30 days, and 1 year after enrollment.
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definition.
|
|
Nervous system disorders
Seizure
|
1.4%
1/73 • Number of events 1 • Adverse event data were collected at 24 hours, 2-7 days, 30 days, and 1 year after enrollment.
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definition.
|
0.00%
0/180 • Adverse event data were collected at 24 hours, 2-7 days, 30 days, and 1 year after enrollment.
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definition.
|
|
General disorders
Weakness/dizziness
|
1.4%
1/73 • Number of events 1 • Adverse event data were collected at 24 hours, 2-7 days, 30 days, and 1 year after enrollment.
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definition.
|
0.00%
0/180 • Adverse event data were collected at 24 hours, 2-7 days, 30 days, and 1 year after enrollment.
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definition.
|
Other adverse events
| Measure |
Randomized to V/Q
n=73 participants at risk
patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control)
V/Q imaging: Standard of care
|
Randomized to CT
n=180 participants at risk
patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media)
Computed tomography scan: Standard of care
|
|---|---|---|
|
General disorders
Emergency Department Visit
|
15.1%
11/73 • Number of events 21 • Adverse event data were collected at 24 hours, 2-7 days, 30 days, and 1 year after enrollment.
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definition.
|
6.1%
11/180 • Number of events 19 • Adverse event data were collected at 24 hours, 2-7 days, 30 days, and 1 year after enrollment.
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definition.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place