Safety of Iodinated Contrast in Liver Transplant Candidates With Decreased Renal Function Undergoing Coronary CT Angiography
NCT ID: NCT03806725
Last Updated: 2022-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2020-06-01
2022-03-30
Brief Summary
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Detailed Description
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This study evaluates the effect of LOCM on liver transplant candidates with normal and decreased renal function undergoing CCTA. Incidence of post-contrast acute kidney injury (PC-AKI) will be compared between the two groups before and after contrast medium exposure.
LOCM is a potential cause of PC-AKI, especially in vulnerable population with decreased renal function. According to the American College of Radiology (ACR) manual on contrast media, however, many published studies on PC-AKI in the past have been heavily contaminated by bias and conflation. More recent studies do not confirm a high risk of contrast induced nephropathy.
End stage liver disease patients with normal renal function do not seem to be at a higher risk of developing PC-AKI. Only limited data reporting a low incidence of PC-AKI after contrast-enhanced CT in patients with liver cirrhosis and concomitant decreased renal function exists. Proof of low PC-AKI in this specific population would allow to redirect patients from invasive catheterization to CCTA as their cardiac clearance before transplantation. This study will prospectively investigate the incidence of PC-AKI in this specific at-risk population.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Liver transplant (LTx) candidates with eGFR>=60
Liver transplant candidates with renal function defined by eGFR above or equal to 60 ml/min/1.73m2, eGFR is determined by Cystatin C measurement.
Intravenous administration of iodinated contrast medium for coronary CT angiography
Administration of iodinated contrast medium for coronary CT angiography
LTx candidates with eGFR<60
Liver transplant candidates with decreased renal function.
Defined by eGFR less than 60 ml/min/1.73m2, eGFR is determined by Cystatin C measurement.
Intravenous administration of iodinated contrast medium for coronary CT angiography
Administration of iodinated contrast medium for coronary CT angiography
Interventions
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Intravenous administration of iodinated contrast medium for coronary CT angiography
Administration of iodinated contrast medium for coronary CT angiography
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Liver transplant candidates who are at high-risk for coronary artery disease and are referred directly to invasive catheterization
* Candidates with chronic kidney disease stage 4, with eGFR \<30 ml/min/1.73m2
* Known or suspected allergy to standard iodine contrast medium
21 Years
75 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Dominik Fleischmann, MD
MD
Locations
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Stanfor University
Stanford, California, United States
Countries
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Other Identifiers
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IRB-45901
Identifier Type: -
Identifier Source: org_study_id
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