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

Withdrawn

• Conditions: Contrast-induced Nephropathy; Contrast Media; Acute Kidney Injury; Liver Transplantation; Renal Insufficiency, Chronic
• Interventions: Diagnostic Test: Intravenous administration of iodinated contrast medium for coronary CT angiography

• Registration Number: NCT03806725
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-16
• Study Start: 2020-06-01
• Primary Completion: 2021-11-22
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-13
• Last Update Posted: 2022-01-04
• Study Completion: 2022-03-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Liver transplant (LTx) candidates with eGFR>=60	Intravenous administration of iodinated contrast medium for coronary CT angiography	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.
LTx candidates with eGFR<60	Intravenous administration of iodinated contrast medium for coronary CT angiography	Liver transplant candidates with decreased renal function. Defined by eGFR less than 60 ml/min/1.73m2, eGFR is determined by Cystatin C measurement.

Primary Outcome Measures

Name	Time	Method
Post-contrast acute kidney injury	Within 5 days after contrast medium exposure.	Incidence of acute kidney injury after iodine contrast medium exposure.

Trial Locations

Locations (1)

Stanfor University; 🇺🇸 Stanford, California, United States