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

Conditions

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

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
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
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

Keywords

Other Study ID Numbers

  • SNUH-2019-0343

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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