Renal Protocol Protection in CKD Patients

Not Applicable

Active, not recruiting

• Conditions: HCC; CKD
• Interventions: Other: Standard dose CT contrast media; Other: low dose CT contrast media

• Registration Number: NCT04024514
• Lead Sponsor: Seoul National University Hospital

Brief Summary

This study aims to investigate whether acceptable image quality is achievable using low contrast media dose and low keV imaging in chronic kidney disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-18
• Study Start: 2019-12-24
• Primary Completion: 2020-12-11
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-30
• Last Update Posted: 2023-03-31
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard dose	Standard dose CT contrast media	Standard CT contrast media dose
Low dose	low dose CT contrast media	Low CT contrast media dose

Primary Outcome Measures

Name	Time	Method
Overall image quality	6 months after complete enrollment	qualitative scoring for image quality on five-point scale (1: worst, 5: excellent, representative value is average score)

Secondary Outcome Measures

Name	Time	Method
Lesion conspicuity	12 months after complete enrollment	qualitative scoring for focal lesion depiction on five-point scale
lesion (HCC) detection	12 months after complete enrollment	detection rate of focal liver lesion/HCC on CT
Incidence of Contrast media-induced nephrotoxicity	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
Contrast media (CM) dose	3 months after complete enrollment	administered CM dose in each group
Image contrast	12 months after complete enrollment	qualitative scoring for image contrast on five-point scale (1: worst, 5: excellent, representative value is average score)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of