Acute Kidney InjuryNCT03806725
Safety of Iodinated Contrast in Liver Transplant Candidates With Decreased Renal Function Undergoing Coronary CT Angiography
An observational study of Acute Kidney Injury and Renal Insufficiency, Chronic, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Acute Kidney Injury, Renal Insufficiency, Chronic, Contrast-induced Nephropathy
- What is being tested?
- Intravenous administration of iodinated contrast medium for coronary CT angiography
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 30 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Liver transplant candidates in evaluation process undergoing cardiac clearance
Who may be able to join
- Liver transplant candidate, age > 21 referred for coronary CT angiography, medium-risk patient for coronary artery disease
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Performance and Iodinated Contrast Safety of Coronary Computed Tomography Angiography in Liver Transplant Candidates With Decreased Renal Function
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.
Read the 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.
- Conditions
- Acute Kidney Injury, Renal Insufficiency, Chronic, Contrast-induced Nephropathy, Liver Transplantation, Contrast Media
- Being tested
- Intravenous administration of iodinated contrast medium for coronary CT angiography
- Keywords
- Contrast-induced Nephropathy, Contrast-induced acute kidney injury, Coronary computed tomography angiography
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous administration of iodinated contrast medium for coronary CT angiographyDiagnostic test
Administration of iodinated contrast medium for coronary CT angiography
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Intravenous administration of iodinated contrast medium for coronary CT angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-contrast acute kidney injury
Incidence of acute kidney injury after iodine contrast medium exposure.
Measured: Within 5 days after contrast medium exposure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start1 Jun 2020 (estimated)
- Primary completion22 Nov 2021 (estimated)
- Study completion30 Mar 2022 (estimated)
Why it stopped: Difficulty with recruitment in this patient population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominik Fleischmann, MD, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806725
- Sponsor's protocol ID
- IRB-45901
- Status last verified
- Dec 2021
- First submitted
- 14 Jan 2019
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance and Iodinated Contrast Safety of Coronary Computed Tomography Angiography in Liver Transplant Candidates With Decreased Renal Function
- ClinicalTrials.gov ID
- NCT03806725
- Acronym / sponsor ID
- IRB-45901
- 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
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Difficulty with recruitment in this patient population.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 22 Nov 2021 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liver transplant (LTx) candidates with eGFR>=60 | – | Diagnostic Test: Intravenous administration of iodinated contrast medium for coronary CT angiographyLiver 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 | – | Diagnostic Test: Intravenous administration of iodinated contrast medium for coronary CT angiographyLiver transplant candidates with decreased renal function. Defined by eGFR less than 60 ml/min/1.73m2, eGFR is determined by Cystatin C measurement. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Liver transplant candidates in evaluation process undergoing cardiac clearance
Key inclusion criteria (1 listed)
- Liver transplant candidate, age > 21 referred for coronary CT angiography, medium-risk patient for coronary artery disease
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous administration of iodinated contrast medium for coronary CT angiographyAdministration of iodinated contrast medium for coronary CT angiography | Diagnostic test | LTx candidates with eGFR<60, Liver transplant (LTx) candidates with eGFR>=60 |
Primary outcome
Post-contrast acute kidney injury
Time frame: Within 5 days after contrast medium exposure.
Incidence of acute kidney injury after iodine contrast medium exposure.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Renal Insufficiency, Chronic, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-contrast acute kidney injury (time frame: Within 5 days after contrast medium exposure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.