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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02991742
Acronym
IDPC
Enrollment
2262
Registered
2016-12-13
Start date
2016-12-31
Completion date
2020-11-30
Last updated
2016-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Failure

Keywords

nephropathy, catheterization, contrast media, ioxaglate, iodixanol, high risk, prevention

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.

Interventions

OTHERcontrast media

Compare 2 contrast media

Sponsors

Instituto Dante Pazzanese de Cardiologia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Contrast-induced nephropathy incidenceBetween 48 and 96 hours after diagnostic and therapeutic cardiac catheterization

Secondary

MeasureTime frameDescription
Composite of death or need for dialysis in 48 to 96 hours and at 30 days after diagnostic and therapeutic cardiac catheterization30 daysNeed 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.
The individual components of the combined outcome (total mortality or dialysis indication)30 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026