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

• Conditions: Acute Kidney Failure
• Interventions: Other: contrast media

• Registration Number: NCT02991742
• Lead Sponsor: Instituto Dante Pazzanese de Cardiologia

Brief Summary

Contrast media-induced nephropathy following diagnostic and therapeutic cardiac catheterization.

Detailed Description

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.

Study Timeline

• Status Verified: 2016-12
• Study Start: 2016-12
• Primary Completion: 2016-12
• Study First Submitted: 2016-12-01
• Study First Submitted QC: 2016-12-09
• Last Update Submitted: 2016-12-12
• Study First Posted: 2016-12-13
• Last Update Posted: 2016-12-14
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2262

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Iodixanol	contrast media	Iodixanol contrast media
Ioxaglate	contrast media	Ioxaglate contrast media

Primary Outcome Measures

Name	Time	Method
Contrast-induced nephropathy incidence	Between 48 and 96 hours after diagnostic and therapeutic cardiac catheterization

Secondary Outcome Measures

Name	Time	Method
The individual components of the combined outcome (total mortality or dialysis indication)	30 days
Composite of death or need for dialysis in 48 to 96 hours and at 30 days after diagnostic and therapeutic cardiac catheterization	30 days	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.