Acute Kidney InjuryVQ/CTNCT03116139
Acute Kidney Injury in Patients Undergoing Contrast Exposure: VQ vs. CT
A study testing V/Q imaging and Computed tomography scan in people with Acute Kidney Injury and Pulmonary Embolism, run by Indiana University at 5 sites in United States.
Trial summary
Both, CT scans and VQ scans, are used by doctors to look for pulmonary embolism. The most common reason to order a VQ scan is to avoid the IV dye. The IV dye used for CT scans can cause kidney problems in some patients, called contrast-induced nephropathy or "CIN." This is a kidney problem that usually does not make… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Pulmonary Embolism, Contrast-induced Nephropathy
- What is being tested?
- V/Q imaging and Computed tomography scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 Jul 2017to 27 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18 years
- CTPA ordered by the treating provider to evaluate PE.
- Pre-test probability of PE ≤20% (defined using the PE Pretest Consult Score)
- For Randomization to CTPA or VQ imaging: Pre-imaging CIN risk ≥25% (CINRisk Score ≥2 points) • A lower-risk subset of 100 patients (CINRisk Score <2) will be enrolled and followed. These patients will complete the CTPA as ordered by their provider (not randomized). Data from this lower-risk subset, along with high-risk patients randomized to CTPA will be used will be used to validate the CINRisk Score, alone and in combination with NGAL and eGFRCYS (Study Aims 1 and 3).
Who cannot join
- History of pulmonary surgery or pulmonary infiltrate, mass or effusion on chest radiograph.
- Clinical instability preventing randomization to CTPA or VQ imaging.
- Pregnancy or ≤48 hours post-partum
- Subject unavailability for reasonable follow-up including biological sample collection, serum creatinine measurement, and interview, such as an insecure residence, planned travel or absence, personal or professional obligations, incarceration, and/or other reason preventing follow-up, identified at enrollment.
- Active renal replacement therapy (hemodialysis or peritoneal dialysis) within 30-days of enrollment or previous physician-directed plans to initiate dialysis within 30-days of the index visit.
- Prior renal transplant or planned within 30-days of enrollment.
- Intravascular contrast administration within 14 days prior to enrollment or planned within 7 days of enrollment.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Baylor, Scott & White Health
Dallas, Texas, 75246
Indiana University Health
Indianapolis, Indiana, 46202
Intermountain Healthcare
Murray, Utah, 84107
Corewell Health
Royal Oak, Michigan, 48073
University of Utah
Salt Lake City, Utah, 84132
About this study
Official title: 1 R01 HL132358: The Contribution of Contrast Media Exposure to Acute Kidney Injury in Patients Evaluated for Pulmonary Embolism in the Emergency Care Setting: a Prospective, Randomized Trial
Both, CT scans and VQ scans, are used by doctors to look for pulmonary embolism. The most common reason to order a VQ scan is to avoid the IV dye. The IV dye used for CT scans can cause kidney problems in some patients, called contrast-induced nephropathy or "CIN." This is a kidney problem that usually does not make patients feel any differently or change how they urinate. Most of the time, it can only be found by testing blood several days later. This kind of kidney problem can be very mild and some patients will never have any symptoms, rarely these problems can be severe. Some patients can also have similar kidney problems for many other reasons (reactions to medications, blood pressure problems, etc.) and can even happen in patients that do not get IV dye. That is why doctors are not sure exactly who will have these problems or if using a test that does not use IV dye can prevent this kidney problem. The VQ scan uses a different medication through the IV that is not IV dye and has not been linked to kidney problems. The purpose of this study is to learn if using the test that does not use IV dye (the "VQ scan") instead of a CT scan in some patients can help to prevent kidney problems.
Read the detailed description
Before the study begins, research personnel will do the following to be sure that patients can be in the study:
- research personnel will talk to the treating physician.
- research personnel will review the patient medical records, blood and urine tests already done for as usual medical care, and chest X-ray.
- research personnel will ask the patients some questions about their health.
- If it has not already been done for usual medical care, patients will be asked to give a urine sample to test for medical conditions that may result in a higher risk of having kidney problems such as having glucose (sugar) in the urine.
If the patient is eligible to continue in the study, the following will also happen at the initial day of enrollment:
- research personnel may draw about 4 tablespoons of blood from the vein or, if from the IV that was (or will be) placed for usual medical care.
- If one of the 100 patients who are at low risk of kidney problems, they will have a CT scan of the chest that was ordered by the doctor.
- Otherwise, the potential subject will be randomly assigned to have either a CT scan of the chest, which will include dye given in an IV, or a VQ scan, that does not use IV dye. One half will have the CT scan and one half will have the VQ scan.
- Potential subjects will also have an ultrasound (a painless sound wave test of the legs to look for a clot in the legs that can cause a clot in the lungs), if the doctor thinks that one is needed, or if the VQ scan is "indeterminate." Indeterminate means that the radiologist, the doctor reading the VQ scan, cannot tell if there is a pulmonary embolism (a clot in your lung). Research personnel expect that less than 5% (5 out of 100) patients will have a VQ scan that is indeterminate. Some patients who have a VQ scan that is indeterminate, may also need to have a CT scan of their chest to be sure that they do or do not have a clot in their lungs.
- research personnel will also save blood and urine samples. Later, these samples will be used to test for electrolytes (salts) and proteins (that may help better predict who will get kidney problems. Subjects will not have to pay for these tests because they will not be used for usual medical care. To protect privacy, research personnel will use a code instead of name to label samples. For this reason, research personnel will not be able to tell the results of these tests.
- If you are not found to be eligible for this study, the reason will be discussed with you and your treating provider. If you are eligible to continue in the study, the following will happen later:
- Subjects will be given an appointment to return to the hospital between 2 and 7 days from the initial visit. As a reminder, research personnel will give subjects a reminder card; research personnel will call and/or text the subjects, and/or email with reminders. If subjects are still in the hospital during this time, research personnel will visit the subjects in the hospital.
- At this appointment research personnel will ask some questions about the health, will take about 4 tablespoons of blood and a urine sample. Blood and urine will be used to test for kidney problems. If these tests do show a kidney problems after having IV dye, research personnel will send a letter to notify subjects and the treating physician.
- In 30 days, research personnel will make 3 attempts to call and ask some questions about the subject's health. If research personnel cannot follow up by telephone, they will also try to contact by text, and/or by mail.
- research personnel will also review medical records in 7 days, 30 days, and in 1 year.
- Being tested
- V/Q imaging, Computed tomography scan
- Keywords
- Computed tomography scan, Ventilation-perfusion lung scan, Acute kidney injury, Pulmonary embolism, Contrast-induced nephropathy
- Medical subject headings
- Acute Kidney Injury, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V/Q imagingDiagnostic test
Also called Ventilation perfusion scan
Standard of care
Computed tomography scanDiagnostic test
Also called CT, CTPA
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Randomized to V/Q | Active comparator | Patients with > 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control) Receives: Diagnostic Test: V/Q imaging |
| Randomized to CT | Active comparator | Patients with > 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media) Receives: Diagnostic Test: Computed tomography scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of Participants Who Developed AKI at 7 Days
Count of participants with a creatinine increase ≥ 0.3 mg/dL or 1.5 times baseline.
Measured: 7 days post enrollment
Secondary outcomes (21)
Count of Participants Who Developed AKI at 30 Day Follow-up
Count of participants with a creatinine increase ≥ 0.3 mg/dL or 1.5 times baseline
Measured: 30 days after enrollment
Count of Participants Who Developed AKI at 1 Year Follow-up
Count of participants with a creatinine increase ≥ 0.3 mg/dL or 1.5 times baseline
Measured: 1 year after enrollment
Count of Participants With an AKI Risk Score ≥2, That Developed AKI Within 7 Days
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.
Measured: Within 7 days of enrollment
Count of Participants With an AKI Risk Score ≥2, That Developed AKI Within 30 Days
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.
Measured: Within 30 days of enrollment
Count of Participants With an AKI Risk Score ≥2, That Developed AKI Within 1 Year
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.
Measured: Within 1 year of enrollment
Count of Participants With an AKI Risk Score <2, That Developed AKI Within 7 Days
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.
Measured: Within 7 days of enrollment
Count of Participants With an AKI Risk Score <2, That Developed AKI Within 30 Days
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.
Measured: Within 30 days of enrollment
Count of Participants With an AKI Risk Score <2, That Developed AKI Within 1 Year
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.
Measured: Within 1 year of enrollment
Count of Participants With an AKI Risk Score ≥2 or Positive Biomarkers, That Developed AKI Within 7 Days
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.
Measured: Within 7 days of enrollment
Count of Participants With an AKI Risk Score ≥2 or Positive Biomarkers, That Developed AKI Within 30 Days
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.
Measured: Within 30 days of enrollment
Count of Participants With an AKI Risk Score ≥2 or Positive Biomarkers, That Developed AKI Within 1 Year
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.
Measured: Within 1 year of enrollment
Count of Participants With an AKI Risk Score <2 and Negative Biomarkers, That Developed AKI Within 7 Days
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.
Measured: Within 7 days of enrollment
Count of Participants With an AKI Risk Score <2 and Negative Biomarkers, That Developed AKI Within 30 Days
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.
Measured: Within 30 days of enrollment
Count of Participants With an AKI Risk Score <2 and Negative Biomarkers,That Developed AKI Within 1 Year
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.
Measured: Within 1 year of enrollment
Count of Participants Who Developed AKI Within 7 Days and Had a Health Outcome
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.
Measured: Within 7 days of enrollment
Count of Participants Who Did Not Develop AKI Within 7 Days and Had a Health Outcome
Count of participants who did not develop AKI within 7 days and had a health outcome
Measured: Within 7 days of enrollment
Count of Participants With Venous Thromboembolism (VTE) Identified on Imaging at Enrollment
Count of participants with Venous Thromboembolism (VTE) identified on imaging at enrollment
Measured: At enrollment
Count of Participants With Venous Thromboembolism (VTE) Identified on Imaging Within 7 Days of Enrollment
Count of participants with Venous Thromboembolism (VTE) identified on imaging within 7 days of enrollment
Measured: Within 7 days of enrollment
Count of Participants With Venous Thromboembolism (VTE) Identified on Imaging Within 30 Days of Enrollment
Count of participants with Venous Thromboembolism (VTE) identified on imaging within 30 days of enrollment
Measured: Within 30 days of enrollment
Count of Participants With Venous Thromboembolism (VTE) Identified on Imaging Within 1 Year of Enrollment
Count of participants with Venous Thromboembolism (VTE) identified on imaging within 1 year of enrollment
Measured: Within 1 year of enrollment
Count of Participants With Venous Thromboembolism (VTE) That Had a Health Outcome
Count of participants with Venous Thromboembolism (VTE) that had a health outcome
Measured: Within 1 year of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start20 Jul 2017
- Primary completion28 Feb 2024
- Study completion27 Mar 2024
Why it stopped: Study funding ended prior to planned study accrual and prior to planned completion of all enrolled subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Alice Mitchell, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116139
- Sponsor's protocol ID
- VQ/CT
- Other IDs
- 1R01HL132358-01A1
- Acronym
- VQ/CT
- Status last verified
- Mar 2026
- First submitted
- 3 Apr 2017
- Last updated
- 23 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1 R01 HL132358: The Contribution of Contrast Media Exposure to Acute Kidney Injury in Patients Evaluated for Pulmonary Embolism in the Emergency Care Setting: a Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT03116139
- Acronym / sponsor ID
- VQ/CT / VQ/CT
- Keywords
- Computed tomography scan, Ventilation-perfusion lung scan, Acute kidney injury, Pulmonary embolism, Contrast-induced nephropathy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study funding ended prior to planned study accrual and prior to planned completion of all enrolled subjects.
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Posted 23 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Both, CT scans and VQ scans, are used by doctors to look for pulmonary embolism. The most common reason to order a VQ scan is to avoid the IV dye. The IV dye used for CT scans can cause kidney problems in some patients, called contrast-induced nephropathy or "CIN." This is a kidney problem that usually does not make patients feel any differently or change how they urinate. Most of the time, it can only be found by testing blood several days later. This kind of kidney problem can be very mild and some patients will never have any symptoms, rarely these problems can be severe. Some patients can also have similar kidney problems for many other reasons (reactions to medications, blood pressure problems, etc.) and can even happen in patients that do not get IV dye. That is why doctors are not sure exactly who will have these problems or if using a test that does not use IV dye can prevent this kidney problem. The VQ scan uses a different medication through the IV that is not IV dye and has not been linked to kidney problems. The purpose of this study is to learn if using the test that does not use IV dye (the "VQ scan") instead of a CT scan in some patients can help to prevent kidney problems.
Detailed description
Before the study begins, research personnel will do the following to be sure that patients can be in the study:
- research personnel will talk to the treating physician.
- research personnel will review the patient medical records, blood and urine tests already done for as usual medical care, and chest X-ray.
- research personnel will ask the patients some questions about their health.
- If it has not already been done for usual medical care, patients will be asked to give a urine sample to test for medical conditions that may result in a higher risk of having kidney problems such as having glucose (sugar) in the urine.
If the patient is eligible to continue in the study, the following will also happen at the initial day of enrollment:
- research personnel may draw about 4 tablespoons of blood from the vein or, if from the IV that was (or will be) placed for usual medical care.
- If one of the 100 patients who are at low risk of kidney problems, they will have a CT scan of the chest that was ordered by the doctor.
- Otherwise, the potential subject will be randomly assigned to have either a CT scan of the chest, which will include dye given in an IV, or a VQ scan, that does not use IV dye. One half will have the CT scan and one half will have the VQ scan.
- Potential subjects will also have an ultrasound (a painless sound wave test of the legs to look for a clot in the legs that can cause a clot in the lungs), if the doctor thinks that one is needed, or if the VQ scan is "indeterminate." Indeterminate means that the radiologist, the doctor reading the VQ scan, cannot tell if there is a pulmonary embolism (a clot in your lung). Research personnel expect that less than 5% (5 out of 100) patients will have a VQ scan that is indeterminate. Some patients who have a VQ scan that is indeterminate, may also need to have a CT scan of their chest to be sure that they do or do not have a clot in their lungs.
- research personnel will also save blood and urine samples. Later, these samples will be used to test for electrolytes (salts) and proteins (that may help better predict who will get kidney problems. Subjects will not have to pay for these tests because they will not be used for usual medical care. To protect privacy, research personnel will use a code instead of name to label samples. For this reason, research personnel will not be able to tell the results of these tests.
- If you are not found to be eligible for this study, the reason will be discussed with you and your treating provider. If you are eligible to continue in the study, the following will happen later:
- Subjects will be given an appointment to return to the hospital between 2 and 7 days from the initial visit. As a reminder, research personnel will give subjects a reminder card; research personnel will call and/or text the subjects, and/or email with reminders. If subjects are still in the hospital during this time, research personnel will visit the subjects in the hospital.
- At this appointment research personnel will ask some questions about the health, will take about 4 tablespoons of blood and a urine sample. Blood and urine will be used to test for kidney problems. If these tests do show a kidney problems after having IV dye, research personnel will send a letter to notify subjects and the treating physician.
- In 30 days, research personnel will make 3 attempts to call and ask some questions about the subject's health. If research personnel cannot follow up by telephone, they will also try to contact by text, and/or by mail.
- research personnel will also review medical records in 7 days, 30 days, and in 1 year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomized to V/Q | Active comparator | Diagnostic Test: V/Q imagingPatients with > 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control) |
| Randomized to CT | Active comparator | Diagnostic Test: Computed tomography scanPatients with > 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age≥18 years
- CTPA ordered by the treating provider to evaluate PE.
- Pre-test probability of PE ≤20% (defined using the PE Pretest Consult Score)
- For Randomization to CTPA or VQ imaging: Pre-imaging CIN risk ≥25% (CINRisk Score ≥2 points) • A lower-risk subset of 100 patients (CINRisk Score <2) will be enrolled and followed. These patients will complete the CTPA as ordered by their provider (not randomized). Data from this lower-risk subset, along with high-risk patients randomized to CTPA will be used will be used to validate the CINRisk Score, alone and in combination with NGAL and eGFRCYS (Study Aims 1 and 3).
Key exclusion criteria (7 listed)
- History of pulmonary surgery or pulmonary infiltrate, mass or effusion on chest radiograph.
- Clinical instability preventing randomization to CTPA or VQ imaging.
- Pregnancy or ≤48 hours post-partum
- Subject unavailability for reasonable follow-up including biological sample collection, serum creatinine measurement, and interview, such as an insecure residence, planned travel or absence, personal or professional obligations, incarceration, and/or other reason preventing follow-up, identified at enrollment.
- Active renal replacement therapy (hemodialysis or peritoneal dialysis) within 30-days of enrollment or previous physician-directed plans to initiate dialysis within 30-days of the index visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V/Q imagingAlso: Ventilation perfusion scanStandard of care | Diagnostic test | Randomized to V/Q |
| Computed tomography scanAlso: CT, CTPAStandard of care | Diagnostic test | Randomized to CT |
Primary outcome
Count of Participants Who Developed AKI at 7 Days
Time frame: 7 days post enrollment
Count of participants with a creatinine increase ≥ 0.3 mg/dL or 1.5 times baseline.
21 secondary outcomes
Count of Participants Who Developed AKI at 30 Day Follow-up
Time frame: 30 days after enrollment
Count of Participants Who Developed AKI at 1 Year Follow-up
Time frame: 1 year after enrollment
Count of Participants With an AKI Risk Score ≥2, That Developed AKI Within 7 Days
Time frame: Within 7 days of enrollment
Count of Participants With an AKI Risk Score ≥2, That Developed AKI Within 30 Days
Time frame: Within 30 days of enrollment
Count of Participants With an AKI Risk Score ≥2, That Developed AKI Within 1 Year
Time frame: Within 1 year of enrollment
Count of Participants With an AKI Risk Score <2, That Developed AKI Within 7 Days
Time frame: Within 7 days of enrollment
Count of Participants With an AKI Risk Score <2, That Developed AKI Within 30 Days
Time frame: Within 30 days of enrollment
Count of Participants With an AKI Risk Score <2, That Developed AKI Within 1 Year
Time frame: Within 1 year of enrollment
Count of Participants With an AKI Risk Score ≥2 or Positive Biomarkers, That Developed AKI Within 7 Days
Time frame: Within 7 days of enrollment
Count of Participants With an AKI Risk Score ≥2 or Positive Biomarkers, That Developed AKI Within 30 Days
Time frame: Within 30 days of enrollment
Count of Participants With an AKI Risk Score ≥2 or Positive Biomarkers, That Developed AKI Within 1 Year
Time frame: Within 1 year of enrollment
Count of Participants With an AKI Risk Score <2 and Negative Biomarkers, That Developed AKI Within 7 Days
Time frame: Within 7 days of enrollment
Count of Participants With an AKI Risk Score <2 and Negative Biomarkers, That Developed AKI Within 30 Days
Time frame: Within 30 days of enrollment
Count of Participants With an AKI Risk Score <2 and Negative Biomarkers,That Developed AKI Within 1 Year
Time frame: Within 1 year of enrollment
Count of Participants Who Developed AKI Within 7 Days and Had a Health Outcome
Time frame: Within 7 days of enrollment
Count of Participants Who Did Not Develop AKI Within 7 Days and Had a Health Outcome
Time frame: Within 7 days of enrollment
Count of Participants With Venous Thromboembolism (VTE) Identified on Imaging at Enrollment
Time frame: At enrollment
Count of Participants With Venous Thromboembolism (VTE) Identified on Imaging Within 7 Days of Enrollment
Time frame: Within 7 days of enrollment
Count of Participants With Venous Thromboembolism (VTE) Identified on Imaging Within 30 Days of Enrollment
Time frame: Within 30 days of enrollment
Count of Participants With Venous Thromboembolism (VTE) Identified on Imaging Within 1 Year of Enrollment
Time frame: Within 1 year of enrollment
Count of Participants With Venous Thromboembolism (VTE) That Had a Health Outcome
Time frame: Within 1 year of enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing V/Q imaging and Computed tomography scan in people with Acute Kidney Injury and Pulmonary Embolism, run by Indiana University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Count of Participants Who Developed AKI at 7 Days (time frame: 7 days post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.