Richard J. Solomon, MD, Madhu K. Natarajan, MD, Serge Doucet, MD, Samin K. Sharma, MD,
Cezar S. Staniloae, MD, Richard E. Katholi, MD, Joseph L. Gelormini, MD, Marino Labinaz, MD,
Abel E. Moreyra, MD, and the Investigators of the CARE Study
- Patients were randomized to receive either iopamidol-370 (n=204) or iodixanol-320 (n=210) as part of
their scheduled cardiac catheterization
- All groups and individuals associated with the study remained blinded to the contrast agents used
- All patients received hydration with isotonic sodium bicarbonate prior, during, and for 6 hours following
the procedure; each site chose whether to administer a prophylactic N-acetylcysteine regimen
- Serum creatinine (SCr) levels and eGFR were assessed at baseline and 2-5 days postdose and
repeated on day 7 if a ≥0.5 mg/dL increase in SCr was observed
- A central laboratory (Covance, Indianapolis, IN) developed study-specific collection kits, performed
all of the baseline and postdose SCr measurements, and calculated eGFR
- The CIN endpoints were defined as a) an absolute increase in SCr ≥0.5 mg/dL (≥44.2 μmol/L) and b)
incidence of a ≥25% increase in SCr or a ≥25% decrease in eGFR from baseline to 45-120 hours after
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This study was supported by a clinical grant from Bracco Diagnostics Inc., Princeton, NJ.
All authors received research support from Bracco Diagnostics Inc. for their participation in the CARE trial. Dr. Solomon is a member of the advisory board and speakers’ bureau for Bracco Diagnostics and Tyco-Mallinckrodt, has served as an expert witness for Bracco Diagnostics, and has received honoraria from Bracco Diagnostics, Tyco-Mallinckrodt, Berlex, and Schering AG. Dr. Katholi is a member of the advisory board and speakers’ bureau for Bracco Diagnostics. Cardiac Angiography in Renally Impaired Patients (CARE) study: a randomized double-blind trial of contrast-induced nephropathy in patients with chronic kidney disease. Solomon RJ, Natarajan MK, Doucet S, Sharma SK, Staniloae CS, Katholi RE, Gelormini JL, Labinaz M, Moreyra AE; Investigators of the CARE Study. Circulation
. 2007 Jun 26;115(25):3189-96.
IMPORTANT SAFETY INFORMATION:
ISOVUE® (iopamidol injection) IS NOT FOR INTRATHECAL USE.
Iopamidol injection is available as
for intrathecal administration.
Nonionic iodinated contrast media inhibit blood coagulation, in vitro, less than ionic contrast media. Clotting has been reported when blood remains in contact with syringes containing nonionic contrast media. Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events.
Caution must be exercised in patients with severely impaired renal function, those with combined renal and hepatic disease, or anuria, particularly when larger or repeat doses are administered. Radiopaque diagnostic contrast agents are potentially hazardous in patients with multiple myeloma or other paraproteinemia, particularly in those with therapeutically resistant anuria. Caution should be exercised in hydrating patients with underlying conditions that may be worsened by fluid overload, such as congestive heart failure. Diabetic nephropathy may predispose to acute renal impairment following intravascular contrast media administration. Acute renal impairment following contrast media administration may precipitate lactic acidosis in patients who are taking biguanides. Preparatory dehydration is dangerous and may contribute to acute renal failure in patients with advanced vascular disease, diabetic patients, and in susceptible nondiabetic patients (often elderly with preexisting renal disease). Patients should be well hydrated prior to and following iopamidol administration.
The possibility of a reaction, including serious, life-threatening, fatal, anaphylactoid or cardiovascular reactions, should always be considered. Patients at increased risk include those with a history of a previous reaction to a contrast medium, patients with a known sensitivity to iodine per se, and patients with a known clinical hypersensitivity (bronchial asthma, hay fever, and food allergies).
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The CARE study enrolled 414 evaluable patients with moderate-to-severe chronic kidney disease (estimated glomerular filtration rate [eGFR], 20-59 mL/min/1.73 m2) undergoing diagnostic cardiac angiography or PCI.
A prospective, multicenter, randomized, double-blind, parallel-group clinical trial to compare the renal tolerability of iopamidol-370 (370 mgI/mL) and iodixanol-320 (320 mgI/mL) in a high-risk patient population.
Compare the incidence of contrast-induced nephropathy (CIN) following the intra-arterial administration
of iopamidol-370 or iodixanol-320 in patients with moderate-to-severe chronic kidney disease undergoing
cardiac angiography or percutaneous coronary interventions (PCI).