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Safety of Iodinated Contrast in Liver Transplant Candidates With Decreased Renal Function Undergoing Coronary CT Angiography

Diagnostic Performance and Iodinated Contrast Safety of Coronary Computed Tomography Angiography in Liver Transplant Candidates With Decreased Renal Function

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03806725
Enrollment
0
Registered
2019-01-16
Start date
2020-06-01
Completion date
2022-03-30
Last updated
2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Contrast-induced Nephropathy, Contrast Media, Liver Transplantation, Renal Insufficiency, Chronic

Keywords

Contrast-induced Nephropathy, Contrast-induced acute kidney injury, Coronary computed tomography angiography

Brief summary

This study evaluates the safety of iodinated contrast medium administered to liver transplant candidates with decreased renal function undergoing coronary CT angiography. Incidence of post-contrast acute kidney injury in liver transplant candidates with decreased renal function and normal renal function will be compared.

Detailed description

Low osmolar non-ionic contrast medium (LOCM) is routinely used for contrast-enhanced computed tomography (CT) including coronary computed tomography angiography (CCTA). 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.

Interventions

DIAGNOSTIC_TESTIntravenous administration of iodinated contrast medium for coronary CT angiography

Administration of iodinated contrast medium for coronary CT angiography

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

\- Liver transplant candidate, age \> 21 referred for coronary CT angiography, medium-risk patient for coronary artery disease

Exclusion criteria

* Liver transplant candidates who are at low-risk for coronary artery disease and therefore do not need coronary CT angiography or invasive catheterization * 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

Design outcomes

Primary

MeasureTime frameDescription
Post-contrast acute kidney injuryWithin 5 days after contrast medium exposure.Incidence of acute kidney injury after iodine contrast medium exposure.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026