- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03116139
Acute Kidney Injury in Patients Undergoing Contrast Exposure: VQ vs. CT (VQ/CT)
September 29, 2023 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
Recruiting
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
700
Phase
- 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
- Name: Alice Mitchell, MD
- Phone Number: (317) 880-3900
- Email: alimitch@iu.edu
Study Contact Backup
- Name: Kate Pettit
- Email: klpettit@iu.edu
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Recruiting
- Indiana University Health
-
Contact:
- Kate Pettit
- Email: klpettit@iu.edu
-
-
Michigan
-
Royal Oak, Michigan, United States, 48073
- Recruiting
- Corewell Health
-
Contact:
- Carol L Clark, MD
- Phone Number: 248-898-3080
- Email: carol.clark@corewellhealth.org
-
Contact:
- Heather Grace
- Phone Number: (248)898-7382
- Email: heather.grace@corewellhealth.org
-
-
Texas
-
Dallas, Texas, United States, 75246
- Completed
- Baylor, Scott & White Health
-
-
Utah
-
Murray, Utah, United States, 84107
- Completed
- Intermountain Healthcare
-
Salt Lake City, Utah, United States, 84132
- Completed
- 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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
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 |
Intervention / Treatment |
---|---|
No Intervention: Low risk for kidney injury with use of CT
No randomization due to low risk for kidney injury.
100 patients undergoing CTPA with an estimated risk of CIN <10% (CINRisk Score <2)
|
|
Active Comparator: Randomized to V/Q
300 patients with > 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control)
|
Standard of care
Other Names:
|
Active Comparator: Randomized to CT
300 patients with > 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media)
|
Standard of care
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute kidney injury in subjects exposed and unexposed to iodinated contrast media
Time Frame: >/= 48 hours to </= 168 hours of enrollment
|
Creatinine increase >/= 25% of baseline
|
>/= 48 hours to </= 168 hours of enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Validate the acute kidney injury score, alone and in combination with acute-phase markers of renal dysfunction.
Time Frame: Enrollment
|
Compare the incidence of short, mid- and long-term AKI and subsequent health outcomes in patients exposed to iodinated contrast media and unexposed controls.
|
Enrollment
|
Validate the acute kidney injury score, alone and in combination with acute-phase markers of renal dysfunction.
Time Frame: 2-7 days post enrollment
|
Compare the incidence of short, mid- and long-term AKI and subsequent health outcomes in patients exposed to iodinated contrast media and unexposed controls.
|
2-7 days post enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
July 1, 2017
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
April 3, 2017
First Submitted That Met QC Criteria
April 11, 2017
First Posted (Actual)
April 14, 2017
Study Record Updates
Last Update Posted (Actual)
October 3, 2023
Last Update Submitted That Met QC Criteria
September 29, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Urologic Diseases
- Renal Insufficiency
- Embolism and Thrombosis
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Embolism
- Wounds and Injuries
- Acute Kidney Injury
- Pulmonary Embolism
Other Study ID 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.
Clinical Trials on Acute Kidney Injury
-
Instituto Nacional de Cardiologia Ignacio ChavezInstituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUnknownKidney Injury, Acute | Acute Renal Injury | Acute Kidney Injuries | Kidney Injuries, Acute | Acute Renal InjuriesMexico
-
Yonsei UniversityCompletedAcute Kidney Injury(Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery)Korea, Republic of
-
University Hospital, GhentWithdrawn
-
Beni-Suef UniversityCairo UniversityRecruitingAKI - Acute Kidney InjuryEgypt
-
University Hospital MuensterBaxter Healthcare CorporationCompletedAcute Kidney Injury (AKI)Spain, France, United States, Turkey, Germany, Egypt, Italy, Libyan Arab Jamahiriya, Malta, North Macedonia, Palestinian Territory, occupied, Russian Federation, Saudi Arabia, Slovenia
-
Chinese PLA General HospitalBeijing Tsinghua Changgeng HospitalCompletedPostoperative Acute Kidney InjuryChina
-
Chinese PLA General HospitalCompletedPostoperative Acute Kidney InjuryChina
-
Astellas Pharma IncCompleted
-
South Egypt Cancer InstituteCompletedAcute Kidney Injury (AKI)Egypt
-
Xuzhou Medical UniversityUnknownPostoperative Acute Kidney Injury
Clinical Trials on V/Q imaging
-
Emory UniversityGeorgia Tech Research Foundation; Georgia Clinical & Translational Science...Enrolling by invitationCOVID-19 | Acute Respiratory Distress SyndromeUnited States
-
University Hospital, BrestRecruitingPulmonary EmbolismFrance, Switzerland
-
University Hospital, BrestRecruiting
-
UMC UtrechtRecruitingPulmonary Embolism | Ventilation Perfusion MismatchNetherlands
-
Assiut UniversityNot yet recruitingCTEPH Predictors
-
Boston Children's HospitalRecruitingOxygen Consumption | Mechanical Ventilation | Metabolism | Calorimetry, IndirectUnited States
-
The University of Texas Health Science Center at...National Cancer Institute (NCI)RecruitingProstate CancerUnited States
-
University Hospital, BrestNot yet recruiting
-
Dana-Farber Cancer InstituteTerminatedGynecologic TumorUnited States