Ioxaglate Versus Iodixanol for the Prevention of Contrast-induced Nephropathy in High-risk Patients (IDPC Trial)

Study Overview
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Brief Summary
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Contrast media-induced nephropathy following diagnostic and therapeutic cardiac catheterization.

Detailed Description
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Contrast-induced acute kidney injury represents a serious complication of procedures requiring administration of iodinated contrast media and is associated with the need for dialysis, prolonged hospitalization, increased costs, and mortality. Contrast-induced nephropathy is defined as an increase of 25% in serum creatinine before the procedure. Iodixanol, a nonionic, dimeric, iso-osmolar contrast medium may be less nephrotoxic than low-osmolar contrast media in high-risk patients. The purpose of this study is to compare iodixanol versus ioxaglate in high risk patients between 48 and 96 hours after procedures that use contrast.

Official Title
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Ioxaglate Versus Iodixanol for the Prevention of Contrast-induced Nephropathy in High-risk Patients After Diagnostic and Therapeutic Cardiac Catheterization (IDPC Trial)

Conditions
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Acute Kidney Failure

Intervention / Treatment
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* Other: contrast media


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least one of the following criteria Aged more than 70 years-old Chronic renal failure Diabetes mellitus Congestive heart failure - left ventricular ejection fraction < 0.50 Shock or intra-aortic ballon pump use Urgency or emergency procedures Exclusion Criteria: Patients in dialysis Allergy to iodine Patient refusal to informed consent

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Iodixanol<br>Iodixanol contrast media | Other: contrast media<br>* Compare 2 contrast media<br>* Other names: Iodixanol X Ioxaglate;|
| Ioxaglate<br>Ioxaglate contrast media | Other: contrast media<br>* Compare 2 contrast media<br>* Other names: Iodixanol X Ioxaglate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast-induced nephropathy incidence |  | Between 48 and 96 hours after diagnostic and therapeutic cardiac catheterization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of death or need for dialysis in 48 to 96 hours and at 30 days after diagnostic and therapeutic cardiac catheterization | Need for dialysis when patient develop end stage kidney failure -- by the time patient lose about 85 to 90 percent of your kidney function and have a glomerular filtration rate of <15. | 30 days | 
| The individual components of the combined outcome (total mortality or dialysis indication) |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high risk, prevention, nephropathy, catheterization, contrast media, ioxaglate, iodixanol