Clinical trial NCT03806725: Safety of Iodinated Contrast in Liver Transplant Candidates With Decreased Renal Function Undergoing Coronary CT Angiography
Official title: Diagnostic Performance and Iodinated Contrast Safety of Coronary Computed Tomography Angiography in Liver Transplant Candidates With Decreased Renal Function
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acute Kidney Injury
Renal Insufficiency, Chronic
Contrast-induced Nephropathy
Liver Transplantation
Contrast Media
Keywords: Contrast-induced Nephropathy
Contrast-induced acute kidney injury
Coronary computed tomography angiography
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Liver transplant candidates in evaluation process undergoing cardiac clearance

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-contrast acute kidney injury
timeFrame: Within 5 days after contrast medium exposure.
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanfor University
state: California
Study officials:
References: