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

NCT03116139 | Terminated Results

• 2 other identifiers: VQ/CT1R01HL132358-01A1
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 5

Brief 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 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.

Conditions

Acute Kidney Injury; Pulmonary Embolism; Contrast-induced Nephropathy

Keywords

Computed tomography scan; Ventilation-perfusion lung scan; Acute kidney injury; Pulmonary embolism; Contrast-induced nephropathy

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days post enrollment

Secondary Outcomes (21)

• Count of Participants Who Developed AKI at 30 Day Follow-up

  30 days after enrollment

• Count of Participants Who Developed AKI at 1 Year Follow-up

  1 year after enrollment

• Count of Participants With an AKI Risk Score ≥2, That Developed AKI Within 7 Days

  Within 7 days of enrollment

• Count of Participants With an AKI Risk Score ≥2, That Developed AKI Within 30 Days

  Within 30 days of enrollment

• Count of Participants With an AKI Risk Score ≥2, That Developed AKI Within 1 Year

  Within 1 year of enrollment

Study Arms (2)

Randomized to V/Q

ACTIVE COMPARATOR

Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control)

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)

Diagnostic Test: Computed tomography scan

Interventions

V/Q imaging DIAGNOSTIC_TEST

Standard of care

Also known as: Ventilation perfusion scan

Randomized to V/Q

Computed tomography scan DIAGNOSTIC_TEST

Standard of care

Also known as: CT, CTPA

Randomized to CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (5)

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

Corewell Health

Royal Oak, Michigan, 48073, United States

Location

Baylor, Scott & White Health

Dallas, Texas, 75246, United States

Location

Intermountain Healthcare

Murray, Utah, 84107, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury; Pulmonary Embolism

Interventions

Ventilation-Perfusion Scan; Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Radionuclide Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Radioisotope; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Image Interpretation, Computer-Assisted; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Results Point of Contact

• Title: Kate Pettit
• Organization: Indiana University

klpettit@iu.edu

317-278-7082

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 14, 2017
• Study Start: July 20, 2017
• Primary Completion: February 28, 2024
• Study Completion: March 27, 2024
• Last Updated: March 23, 2026
• Results First Posted: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)