Acute Kidney Injury in Patients Undergoing Contrast Exposure: VQ vs. CT (VQ/CT)

March 3, 2026 updated by: Alice Mitchell, Indiana University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
253

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Alice Mitchell, MD
  • Phone Number: (317) 880-3900
  • Email: alimitch@iu.edu

Study Contact Backup

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Corewell Health
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor, Scott & White Health
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Healthcare
      • Salt Lake City, Utah, United States, 84132
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age≥18 years
  2. CTPA ordered by the treating provider to evaluate PE.
  3. Pre-test probability of PE ≤20% (defined using the PE Pretest Consult Score)
  4. 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).

Exclusion Criteria:

  1. History of pulmonary surgery or pulmonary infiltrate, mass or effusion on chest radiograph.
  2. Clinical instability preventing randomization to CTPA or VQ imaging.
  3. Pregnancy or ≤48 hours post-partum
  4. 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.
  5. 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.
  6. Prior renal transplant or planned within 30-days of enrollment.
  7. Intravascular contrast administration within 14 days prior to enrollment or planned within 7 days of enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Randomized to V/Q
Patients with > 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control)
Diagnostic test: V/Q imaging
Standard of care
Other Names:
  • Ventilation perfusion scan
Active Comparator: Randomized to CT
Patients with > 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media)
Diagnostic test: Computed tomography scan
Standard of care
Other Names:
  • CT
  • CTPA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
7 days post enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Count of Participants Who Developed AKI at 30 Day Follow-up
Time Frame: 30 days after enrollment
Count of participants with a creatinine increase ≥ 0.3 mg/dL or 1.5 times baseline
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 a creatinine increase ≥ 0.3 mg/dL or 1.5 times baseline
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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 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.
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 who did not develop AKI within 7 days and had a health outcome
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 at enrollment
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 7 days of enrollment
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 30 days of enrollment
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) identified on imaging within 1 year of enrollment
Within 1 year of enrollment
Count of Participants With Venous Thromboembolism (VTE) That Had a Health Outcome
Time Frame: Within 1 year of enrollment
Count of participants with Venous Thromboembolism (VTE) that had a health outcome
Within 1 year of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indiana University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 27, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VQ/CT
  • 1R01HL132358-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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