Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Coronary Angiography

Summary

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. 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.

Timeline

Start

2005-08

Primary completion

—

Completion

—

Outcome

Missed primary endpoint

paper iodixanol arm was 0.10 mg/dL, whereas in the iopamidol arm, the median peak increase was 0.09 mg/dL (P = .13). PMID 19853704 ↗

paper The overall CIN incidence was 10.5% (11.2% % in the iodixanol arm and 9.8% in the iopamidol arm, P = .7). PMID 19853704 ↗

paper There was no significant difference between iodixanol and iopamidol in either peak increase in SCr or risk of CIN. PMID 19853704 ↗

Publications

• Laskey W, Aspelin P, Davidson C, Rudnick M, Aubry P, Kumar S, Gietzen F, Wiemer M; DXV405 Study Group. Nephrotoxicity of iodixanol versus iopamidol in patients with chronic kidney disease and diabetes mellitus undergoing coronary angiographic procedures. Am Heart J. 2009 Nov;158(5):822-828.e3. doi: 10.1016/j.ahj.2009.08.016.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Iodixanol	Diagnostic / imaging agent	320 mg/ml	—

Indications