An observational study in Acute Kidney Injury, Renal Insufficiency, Chronic and Contrast-induced Nephropathy, sponsored by Stanford University. Withdrawn at 1 site in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-01-04.
Sponsored by Stanford University · Observational
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.
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.
1,594 studies on the registry are indexed under Acute Kidney Injury; 370 are open to participants now.
Browse Acute Kidney Injury studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
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Liver transplant candidates in evaluation process undergoing cardiac clearance
Exclusion Criteria:
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.
Diagnostic Test: 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.
Diagnostic Test: Intravenous administration of iodinated contrast medium for coronary CT angiography
Administration of iodinated contrast medium for coronary CT angiography
Post-contrast acute kidney injury
Incidence of acute kidney injury after iodine contrast medium exposure.
Time frame: Within 5 days after contrast medium exposure.
Plan to share: No
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