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

December 12, 2016 updated by: RAFAELA ANDRADE PENALVA FREITAS, Instituto Dante Pazzanese de Cardiologia

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

2262

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing coronary angiography or percutaneous interventions will be eligible for the trial if they have at least 1 risk factor for contrast-induced acute kidney injury

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Iodixanol
Iodixanol contrast media
Other: contrast media
Compare 2 contrast media
Other Names:
  • Iodixanol X Ioxaglate
Ioxaglate
Ioxaglate contrast media
Other: contrast media
Compare 2 contrast media
Other Names:
  • Iodixanol X Ioxaglate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Contrast-induced nephropathy incidence
Time Frame: Between 48 and 96 hours after diagnostic and therapeutic cardiac catheterization
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
Time Frame: 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.
30 days
The individual components of the combined outcome (total mortality or dialysis indication)
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Dante Pazzanese de Cardiologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

December 1, 2016

First Submitted That Met QC Criteria

December 9, 2016

First Posted (Estimate)

December 13, 2016

Study Record Updates

Last Update Posted (Estimate)

December 14, 2016

Last Update Submitted That Met QC Criteria

December 12, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 58593116.2.0000.5462

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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