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

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Stanford University

Status

Withdrawn

Conditions

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

Treatments

Diagnostic Test: Intravenous administration of iodinated contrast medium for coronary CT angiography

Study type

Observational

Funder types

Other

Identifiers

NCT03806725
IRB-45901

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

21 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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