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

NCT ID: NCT02991742

Last Updated: 2016-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2262 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2020-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Acute Kidney Failure

Keywords

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nephropathy catheterization contrast media ioxaglate iodixanol high risk prevention

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Iodixanol

Iodixanol contrast media

contrast media

Intervention Type OTHER

Compare 2 contrast media

Ioxaglate

Ioxaglate contrast media

contrast media

Intervention Type OTHER

Compare 2 contrast media

Interventions

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contrast media

Compare 2 contrast media

Intervention Type OTHER

Other Intervention Names

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Iodixanol X Ioxaglate

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Dante Pazzanese de Cardiologia

OTHER

Sponsor Role lead

Responsible Party

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RAFAELA ANDRADE PENALVA FREITAS

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Freitas RAP, Tanajura LF, Mehran R, Chamie D, Chaves A, Centemero M, Braga S, Costa R, Cao D, Sousa A, Feres F, Costa JR Jr. Ioxaglate Versus IoDixanol for the Prevention of Contrast-Induced Nephropathy: The IDPC Trial. J Invasive Cardiol. 2023 Jun;35(6):E281-E290. doi: 10.25270/jic/21.00249. Epub 2023 May 16.

Reference Type DERIVED
PMID: 37220640 (View on PubMed)

Other Identifiers

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58593116.2.0000.5462

Identifier Type: -

Identifier Source: org_study_id