Ioxaglate Versus Iodixanol for the Prevention of Contrast... | NCT02991742

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

NCT02991742

Sponsor

Instituto Dante Pazzanese de Cardiologia

Status

Unknown status

Last Update Posted

Dec 14, 2016Estimated

Enrollment

2,262Estimated

Phase

Not provided

Conditions

Acute Kidney Failure

Interventions

contrast media

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Dec 2016Actual

Completion Date

Nov 2020Estimated

First Submitted Date

Dec 1, 2016

First Submission Date that Met QC Criteria

Dec 9, 2016

First Posted Date

Dec 13, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2016

Last Update Posted Date

Dec 14, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

RAFAELA ANDRADE PENALVA FREITAS, Principal Investigator, Instituto Dante Pazzanese de CardiologiaPrincipal Investigator

Lead Sponsor

Instituto Dante Pazzanese de CardiologiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,262Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Iodixanol		Iodixanol contrast media	Other: contrast media
Ioxaglate		Ioxaglate contrast media	Other: contrast media

Interventions

Name	Type	Description	Arm Group Labels	Other Names
contrast media	Other	Compare 2 contrast media	Iodixanol Ioxaglate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Contrast-induced nephropathy incidence		Between 48 and 96 hours after diagnostic and therapeutic cardiac catheterization

Secondary Outcomes

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	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37220640	Derived	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.

ID	Term
D058186	Acute Kidney Injury
D007674	Kidney Diseases

ID	Term
D051437	Renal Insufficiency
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

ID	Term
D064907	Diagnostic Uses of Chemicals
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D020313	Specialty Uses of Chemicals