Clinical trial NCT00823628: Contrast-medium Induced Nephrotoxicity in Patients Undergoing Coronary Angiography - Iodixanol Versus Iopromide
Official title: Comparison of Contrast-medium Induced Nephrotoxicity Between Iodixanol and Iopromide in Patients With Renal Insufficiency Undergoing Coronary Angiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Renal Insufficiency
Coronary Angiography
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2009-01-15
Enrollment: 420
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the treatment of coronary heart disease which is the major cause of heart attack, direct mechanical treatment with catheters such as the coronary angiography, coronary balloon intervention and stenting intervention are the mainstay of therapy in recent years. In that procedures, the investigators should use the contrast media, and it may cause kidney toxicity especially in the patients with underlying kidney disease and decreased kidney function. The investigators intended to find out which contrast agent has less kidney toxicity in the catheter based treatment of coronary arterial diseases in patients with underlying decreased kidney function

Detailed description: Iodixanol, a nonionic, dimeric, iso-osmolar contrast medium (IOCM), may be less nephrotoxic than nonionic, monomeric, low-osmolar contrast media (LOCMs) in high-risk patients. We compared the nephrotoxicity of iodixanol with that of iopromide, an nonionic, monomeric LOCM, in patients with renal impairment.

Eligibility criteria: Inclusion Criteria:

* patients who undergo coronary catheterization
* creatinine clearance rates ≤ 60 mL/min using the Cockcroft-Gault formula

Exclusion Criteria:

* pregnancy or lactation
* having received contrast media within 7 days of study entry
* emergent coronary angiography
* acute renal failure or end-stage renal disease requiring dialysis
* history of hypersensitivity reaction to contrast media
* unstable hemodynamic states such as cardiogenic shock, pulmonary edema or needing mechanical ventilation
* multiple myeloma
* parenteral use of diuretics
* use of N-acetylcysteine
* use of metformin or nonsteroidal anti-inflammatory drugs within 48 hours of the procedure

Primary outcomes:
measure: Incidence of contrast induced nephropathy, defined as either a relative increase in serum creatinine from baseline of >=25% or an absolute increase of >=0.5mg/dL(44.2µmol/L)
timeFrame: days 1 and 2
Secondary outcomes:
measure: proportion of patients exhibiting an increase in serum creatinine of >=0.5mg/dL(44.2µmol/L), the proportion with a >=1.0 mg/dL(88.4µmol/L) increase in serum creatinine, and the mean peak increase in serum creatinine
timeFrame: days 1 and 2
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Cardiovascular Center, Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Facility: Cardiovascular Center, Seoul National University Bundang Hospital
name: Tae-Jin Youn, MD, PhD
role: STUDY_DIRECTOR
References: