Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography
Summary
It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
Description
GEHC has decided not to provide this detail
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Conditions
Renal Insufficiency
Intervention
Iodixanol 320 mg I/mL (Visipaque™), iopamidol 300 mg I/mL (IsoVue)
Location
GE Healthcare
Princeton
New Jersey
United States
08540
Status
Recruiting
Source
GE Healthcare
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00209417
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:49:22-0400
Clinical Trials
Renal Safety of Iopamidol vs. Iodixanol During Coronary Angiography in Diabetic Patients
The purpose of this study is to compare the incidence of contrast-induced nephropathy (CIN) following the administration of iopamidol-370 (Iopamiro-370) and iodixanol-320 (Visipaque 320) i...
Patients With Renal Impairment and Diabetes Undergoing Computed Tomography (CT)
The main purpose of this study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue (iopamidol) or Visipaque in diabetic patients with mode...
A Study of Two Iodinated Contrast Agents in Renally Impaired Patients Undergoing Cardiac Angiography
The main purpose of this study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue or Visipaque in patients with moderate to severe renal ...
The purpose of this study is to compare ISOVUE-250 and VISIPAQUE 270 for motion artifact and pain following intraarterial injection for peripheral DSA.
A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients
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).
PubMed Articles
To compare the nephrotoxic effects of iodixanol and iopamidol in patients undergoing peripheral angiography.
Recent progress in angiography and interventional therapy has revived interest in comparison of nephrotoxicity of low-or iso-osmolar contrast media, but detailed mechanisms and effective treatments of...
ACE Inhibitors and ARB in Chronic Kidney Disease: What Has to Be Considered.
Proteinuric kidney disease, especially in the early and middle stages of renal insufficiency, may be favorably affected by ACE-I/ARB. The progression of renal insufficiency is thereby slowed down and ...
Preoperative renal insufficiency is an independent predictor of mortality after coronary artery bypass graft (CABG) surgery. However, there are few reports aimed to evaluate the impact of mild preoper...
This study examined the electrochemical (EC) reduction of iodinated contrast media (ICM) exemplified by iopamidol and diatrizoate. The method of rotating ring-disc electrode (RRDE) was used to elucida...
Medical and Biotech [MESH] Definitions
Renal Insufficiency
Conditions in which the KIDNEYS perform below the normal level in the ability to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal insufficiency can be classified by the degree of kidney damage (as measured by the level of PROTEINURIA) and reduction in GLOMERULAR FILTRATION RATE. The most severe form is KIDNEY FAILURE. Renal function may deteriorate slowly (RENAL INSUFFICIENCY, CHRONIC) or precipitously (RENAL INSUFFICIENCY, ACUTE).
Nephrocalcinosis
A condition characterized by calcification of the renal tissue itself. It is usually seen in distal RENAL TUBULAR ACIDOSIS with calcium deposition in the DISTAL KIDNEY TUBULES and the surrounding interstitium. Nephrocalcinosis causes RENAL INSUFFICIENCY.
Renal Insufficiency, Chronic
Conditions in which the KIDNEYS perform below the normal level for more than three months. Chronic kidney insufficiency is classified by five stages according to the decline in GLOMERULAR FILTRATION RATE and the degree of kidney damage (as measured by the level of PROTEINURIA). The most severe form is the end-stage renal disease (CHRONIC KIDNEY FAILURE). (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002)
Uranyl Nitrate
Bis(nitrato-O)dioxouranium. A compound used in photography and the porcelain industry. It causes severe renal insufficiency and renal tubular necrosis in mammals and is an effective lymphocyte mitogen.
Cardio-renal Syndrome
Condition where a primary dysfunction of either heart or kidney results in failure of the other organ (e.g., HEART FAILURE with worsening RENAL INSUFFICIENCY).
