Back to resultsContrast-inDuced nephRotoxicity as Assessed by the KIdney Load-to-DAmage RElationship (DrKILDARE)
Primary Purpose
Contrast Induced Acute Kidney Injury
Status
Completed
Phase
Early Phase 1
Locations
Italy
Study Type
Interventional
Intervention
Iobitridol 350
Iodixanol 320
Sponsored by
About this trial
This is an interventional prevention trial for Contrast Induced Acute Kidney Injury focused on measuring acute kidney injury, contrast media, cystatin-C
Eligibility Criteria
Inclusion Criteria:
- Patients candidate to coronary angiography and/or angioplasty and
- Baseline creatinine clearance < 60 ml/min
Exclusion Criteria:
- Patients with STEMI
- Patients with shock
- Known allergy to contrast media
- Prior contrast administration within 1 month
- Current use of nonsteroidal anti-inflammatory drugs
Sites / Locations
- Misericordia Hospital, ASL 9
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Iodixanol
Iobitridol
Arm Description
Patients randomized to coronary angiography/angioplasty with Iodixanol 320
Patients randomized to coronary angiography/angioplasty with Iobitridol 350
Outcomes
Primary Outcome Measures
Slope of LDR (as assessed by serum cystatin-C changes)
Slope of the relationship plotting individual iodine loads against serum cystatin-C changes at 48 hours after catheterization
Secondary Outcome Measures
Slope of LDR (as assessed by serum creatinine changes)
Slope of the relationship plotting individual iodine loads against serum creatinine changes at 72 hours after catheterization
Full Information
NCT ID
NCT01908309
First Posted
July 23, 2013
Last Updated
June 22, 2015
Sponsor
Azienda Sanitaria Locale 9, Grosseto
1. Study Identification
Unique Protocol Identification Number
NCT01908309
Brief Title
Contrast-inDuced nephRotoxicity as Assessed by the KIdney Load-to-DAmage RElationship
Acronym
DrKILDARE
Official Title
Contrast-inDuced nephRotoxicity as Assessed by the Cystatin-modified KIdney Load-to-DAmage RElationship
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Sanitaria Locale 9, Grosseto
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
We previously demonstrated that the slope of the relationship plotting individual iodine loads against contrast-induced serum creatinine changes ( the load-to-damage relationship, LDR) characterizes the intrinsic nephrotoxicity of the contrast. Aim of the present study is to compare, through the assessment of the LDR slope, the intrinsic nephrotoxicity of two different contrast media using serum cystatin-C changes as the LDR dependent variable.
Detailed Description
We previously demonstrated that the slope of the relationship plotting individual iodine loads against contrast-induced serum creatinine changes ( the load-to-damage relationship, LDR) characterizes the intrinsic nephrotoxicity of the contrast and it may allow for reliable comparative evaluations among small sized study groups randomized to different contrast media. The aim of the present study is to compare, through the assessment of the LDR slope, the intrinsic nephrotoxicity of two different contrast media using serum cystatin-C changes as the LDR dependent variable.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast Induced Acute Kidney Injury
Keywords
acute kidney injury, contrast media, cystatin-C
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Iodixanol
Arm Type
Active Comparator
Arm Description
Patients randomized to coronary angiography/angioplasty with Iodixanol 320
Arm Title
Iobitridol
Arm Type
Active Comparator
Arm Description
Patients randomized to coronary angiography/angioplasty with Iobitridol 350
Intervention Type
Drug
Intervention Name(s)
Iobitridol 350
Intervention Type
Drug
Intervention Name(s)
Iodixanol 320
Primary Outcome Measure Information:
Title
Slope of LDR (as assessed by serum cystatin-C changes)
Description
Slope of the relationship plotting individual iodine loads against serum cystatin-C changes at 48 hours after catheterization
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Slope of LDR (as assessed by serum creatinine changes)
Description
Slope of the relationship plotting individual iodine loads against serum creatinine changes at 72 hours after catheterization
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients candidate to coronary angiography and/or angioplasty and
Baseline creatinine clearance < 60 ml/min
Exclusion Criteria:
Patients with STEMI
Patients with shock
Known allergy to contrast media
Prior contrast administration within 1 month
Current use of nonsteroidal anti-inflammatory drugs
Facility Information:
Facility Name
Misericordia Hospital, ASL 9
City
Grosseto
ZIP/Postal Code
58100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
23811842
Citation
Limbruno U, Picchi A, Micheli A, Calabria P, Cortese B, Brizi G, Severi S, De Caterina R. Refining the assessment of contrast-induced acute kidney injury: the load-to-damage relationship. J Cardiovasc Med (Hagerstown). 2014 Jul;15(7):587-94. doi: 10.2459/JCM.0b013e3283638e56.
Results Reference
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Contrast-inDuced nephRotoxicity as Assessed by the KIdney Load-to-DAmage RElationship
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