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出境医 / 临床实验 / Renal Protocol Protection in CKD Patients

Renal Protocol Protection in CKD Patients

Study Description
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.

Condition or disease Intervention/treatment Phase
HCC CKD Other: low dose CT contrast media Other: Standard dose CT contrast media Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Development of Renal Protection Protocol Using Low Dose Contrast Media and Spectral Computed Tomography in Chronic Kidney Disease Patients
Actual Study Start Date : December 24, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Low dose
Low CT contrast media dose
 Other: low dose CT contrast media
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
 Other: Standard dose CT contrast media
CT contrast media (Ioversol 350mgI/kg) is administrated at a dose of 525mgI/kg in standard dose group.
Outcome Measures
Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Contrast media (CM) dose [ Time Frame: 3 months after complete enrollment ]
    administered CM dose in each group

  2. 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. 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)

  4. Lesion conspicuity [ Time Frame: 12 months after complete enrollment ]
    qualitative scoring for focal lesion depiction on five-point scale

  5. lesion (HCC) detection [ Time Frame: 12 months after complete enrollment ]
    detection rate of focal liver lesion/HCC on CT


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations

Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jeong Min Lee, MD Seoul National University Hospital
Tracking Information
First Submitted Date  ICMJE July 17, 2019
First Posted Date  ICMJE July 18, 2019
Last Update Posted Date March 17, 2021
Actual Study Start Date  ICMJE December 24, 2019
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2019) 		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)
Original Primary Outcome Measures  ICMJE
 (submitted: July 17, 2019) 		Overall image quality [ Time Frame: 6 months after complete enrollment ]
qualitative scoring for image quality on five-point scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2019)
  • Contrast media (CM) dose [ Time Frame: 3 months after complete enrollment ]
    administered CM dose in each group
  • 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
  • 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)
  • Lesion conspicuity [ Time Frame: 12 months after complete enrollment ]
    qualitative scoring for focal lesion depiction on five-point scale
  • lesion (HCC) detection [ Time Frame: 12 months after complete enrollment ]
    detection rate of focal liver lesion/HCC on CT
Original Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2019)
  • Contrast media dose [ Time Frame: 3 months after complete enrollment ]
    administered CM dose in each group
  • 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
  • Image contrast [ Time Frame: 12 months after complete enrollment ]
    qualitative scoring for image contrast on five-point scale
  • Lesion conspicuity [ Time Frame: 12 months after complete enrollment ]
    qualitative scoring for focal lesion depiction on five-point scale
  • lesion (HCC) detection [ Time Frame: 12 months after complete enrollment ]
    detection rate of focal liver lesion/HCC on CT
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Renal Protocol Protection in CKD Patients
Official Title  ICMJE Development of Renal Protection Protocol Using Low Dose Contrast Media and Spectral Computed Tomography in Chronic Kidney Disease Patients
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE
  • HCC
  • CKD
Intervention  ICMJE
  • Other: low dose CT contrast media
    CT contrast media (Ioversol 320mgI/kg) is administrated at a dose of 300mgI/kg in low dose group
  • Other: Standard dose CT contrast media
    CT contrast media (Ioversol 350mgI/kg) is administrated at a dose of 525mgI/kg in standard dose group.
Study Arms  ICMJE
  • Experimental: Low dose
    Low CT contrast media dose
    Intervention: Other: low dose CT contrast media
  • Active Comparator: Standard dose
    Standard CT contrast media dose
    Intervention: Other: Standard dose CT contrast media
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 17, 2019) 		52
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04024514
Other Study ID Numbers  ICMJE SNUH-2019-0343
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jeong Min Lee, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeong Min Lee, MD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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