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

Acute Kidney Failure Clinical Trial

— IDPC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02991742
• Other study ID #: 58593116.2.0000.5462
• Status: Not yet recruiting
• Phase: N/A
• First received: December 1, 2016
• Last updated: December 12, 2016
• Start date: December 2016
• Est. completion date: November 2020

Study information

• Verified date: December 2016
• Source: Instituto Dante Pazzanese de Cardiologia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2262
• Est. completion date: November 2020
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Failure
• Acute Kidney Injury
• Kidney Diseases
• Renal Insufficiency

Intervention

Other:
• contrast media
Compare 2 contrast media

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Dante Pazzanese de Cardiologia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast-induced nephropathy incidence		Between 48 and 96 hours after diagnostic and therapeutic cardiac catheterization	Yes
Secondary	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	Yes
Secondary	The individual components of the combined outcome (total mortality or dialysis indication)		30 days	Yes