Contrast-inDuced nephRotoxicity as Assessed by the KIdney Load-to-DAmage RElationship

Study Overview
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Brief Summary
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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
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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.

Official Title
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Contrast-inDuced nephRotoxicity as Assessed by the Cystatin-modified KIdney Load-to-DAmage RElationship

Conditions
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Contrast Induced Acute Kidney Injury

Intervention / Treatment
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* Drug: Iobitridol 350
* Drug: Iodixanol 320


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Iodixanol<br>Patients randomized to coronary angiography/angioplasty with Iodixanol 320 | Drug: Iodixanol 320<br> <br> |
| Active Comparator: Iobitridol<br>Patients randomized to coronary angiography/angioplasty with Iobitridol 350 | Drug: Iobitridol 350<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute kidney injury, contrast media, cystatin-C