- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04024514
Renal Protocol Protection in CKD Patients
March 30, 2023 updated by: Jeong Min Lee, Seoul National University Hospital
Development of Renal Protection Protocol Using Low Dose Contrast Media and Spectral Computed Tomography in Chronic Kidney Disease Patients
This study aims to investigate whether acceptable image quality is achievable using low contrast media dose and low keV imaging in chronic kidney disease.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Seoul National University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- High risk group for developing HCC
- Scheduled contrast-enhanced CT for HCC diagnosis or surveillance
- chronic kidney disease (Estimated GFR < 60mL/min/1.73m2)
Exclusion Criteria:
- not a high risk group for developing HCC
- congestive hepatopathy
- on dialysis
- no venous access on forearm
- anticipated beam hardening artifact due to prosthesis
- relative/absolute contra-indication of contrast-enhanced CT except CKD (Estimated GFR < 60mL/min/1.73m2)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low dose
Low CT contrast media dose
|
CT contrast media (Ioversol 320mgI/kg) is administrated at a dose of 300mgI/kg in low dose group
|
Active Comparator: Standard dose
Standard CT contrast media dose
|
CT contrast media (Ioversol 350mgI/kg) is administrated at a dose of 525mgI/kg in standard dose group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall image quality
Time Frame: 6 months after complete enrollment
|
qualitative scoring for image quality on five-point scale (1: worst, 5: excellent, representative value is average score)
|
6 months after complete enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Contrast media (CM) dose
Time Frame: 3 months after complete enrollment
|
administered CM dose in each group
|
3 months after complete enrollment
|
Incidence of Contrast media-induced nephrotoxicity
Time Frame: 3 days after contrast media administration
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serum Cr level increase by 25% or more of the baseline, or 0.5mg/dl in 3 days after contrast media administration without other cause
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3 days after contrast media administration
|
Image contrast
Time Frame: 12 months after complete enrollment
|
qualitative scoring for image contrast on five-point scale (1: worst, 5: excellent, representative value is average score)
|
12 months after complete enrollment
|
Lesion conspicuity
Time Frame: 12 months after complete enrollment
|
qualitative scoring for focal lesion depiction on five-point scale
|
12 months after complete enrollment
|
lesion (HCC) detection
Time Frame: 12 months after complete enrollment
|
detection rate of focal liver lesion/HCC on CT
|
12 months after complete enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 24, 2019
Primary Completion (Actual)
December 11, 2020
Study Completion (Anticipated)
September 30, 2023
Study Registration Dates
First Submitted
July 17, 2019
First Submitted That Met QC Criteria
July 17, 2019
First Posted (Actual)
July 18, 2019
Study Record Updates
Last Update Posted (Actual)
March 31, 2023
Last Update Submitted That Met QC Criteria
March 30, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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