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

NCT03806725 | Withdrawn DMC FDA Drug

• 1 other identifier: IRB-45901
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Post-contrast acute kidney injury

  Incidence of acute kidney injury after iodine contrast medium exposure.

  Within 5 days after contrast medium exposure.

Study Arms (2)

Liver transplant (LTx) candidates with eGFR>=60

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

LTx candidates with eGFR<60

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

Interventions

Intravenous administration of iodinated contrast medium for coronary CT angiography DIAGNOSTIC_TEST

Administration of iodinated contrast medium for coronary CT angiography

LTx candidates with eGFR<60; Liver transplant (LTx) candidates with eGFR>=60

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Liver transplant candidates in evaluation process undergoing cardiac clearance

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanfor University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 16, 2019
• Study Start: June 1, 2020
• Primary Completion: November 22, 2021
• Study Completion: March 30, 2022
• Last Updated: January 4, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)