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

Instituto Dante Pazzanese de Cardiologia

Status: Unknown

Conditions: Acute Kidney Failure

Treatments: Other: contrast media

Study type: Observational

Funder types: Other

Identifiers

NCT02991742

58593116.2.0000.5462

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,262 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,262 participants in 2 patient groups

Iodixanol

Description:

Iodixanol contrast media

Treatment:

Other: contrast media

Ioxaglate

Description:

Ioxaglate contrast media

Treatment:

Other: contrast media