A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients

A Randomized, Double-blinded Comparison of Iopromide and Iodixanol in Renally Impaired Patients Undergoing Cardiac Catheterization

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00926562

Acronym

DIRECT

Enrollment

592

Registered

2009-06-23

Start date

2009-02-28

Completion date

2011-05-31

Last updated

2011-06-27

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

Conditions

Kidney Failure, Chronic

Keywords

Contrast Induced Nephropathy, CIN, Cardiac Catheterization

Brief summary

The investigators intend to find out which contrast agent has less kidney toxicity in renal impaired patients undergoing cardiac angiography or percutaneous coronary intervention (PCI).

Detailed description

In the diagnosis and treatment of coronary heart disease, patients should undergo cardiac angiography or percutaneous coronary intervention (PCI). In those procedures, the investigators should use the contrast media, and it may cause kidney toxicity especially in the patients with chronic renal insufficiency.

Interventions

DRUGIopromide (Ultravist)

Iopromide (contrast agent), 370 mgl/ml, an nonionic, monomeric, LOCM

DRUGIodixanol (Visipaque)

Iodixanol (contrast agent) 320 mgl/ml, a nonionic, dimeric, IOCM

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 18 years old or older * Plan to undergo Cardiac Catheterization * Signed ICF * eGFR: 30\ 59 mL/min/1.73m2

Exclusion criteria

* Pregnancy * Under dialysis * Conditions interfering with Cardiac Catheterization * Participation in other trials * Allergic to X-ray contrast media * Administration of any investigational drug within the previous 30 days * Intra-arterial or intravenous administration of iodinated contrast medium from 7 days before to 72 hours after the administration of study drug * Left ventricular ejection fraction (LVEF) less than 30% by ultrasound examination * Intake of any nephrotoxic medications 24 hours before or after the administration of study drug

Design outcomes

Primary

Measure	Time frame
Proportion of patients exhibiting a relative increase in serum creatinine >= 50% from baseline.	day 3 postreatment

Secondary

Measure	Time frame
Proportion of patients developing acute renal failure.	day 30 postreatment
Incidence of a postdose SCr increase ≧25%, a postdose SCr increase ≧1mg/dL, a postdose SCr increase ≧0.5mg/dL, a postdose eGFR decrease ≧25%	days 3

Countries

China

Outcome results

None listed

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