A double-blind randomized clinical study of the safety, tolerability and efficacy of Hexabrix in pediatric angiocardiography.

Abstract

Hexabrix, a low-osmolality radiographic contrast agent consisting of the meglumine and sodium salt of ioxaglic acid (600 mOsm/kg), was evaluated in 50 children undergoing cardiac catheterization in a randomized double-blind manner. In comparison with a conventional radiographic contrast agent (Renografin-76), Hexabrix produced a marked reduction in the pain or discomfort after the injection. Neither agent produced any significant change in pulse or respiratory rates or blood pressure. Changes in left and right ventricular pressures were small and comparable for both groups. Significant dysrhythmias were not noted. There was no evidence of deterioration in renal or hepatic function in either group. Serum LDH and CPK increased comparably with both contrast agents but without any definite evidence of myocardial injury. Postinjection increases in serum osmolality were slightly, but not significantly, higher with Renografin. In the first few hours following the procedure there was an increase in circulating segmented neutrophils and a reciprocal decrease in lymphocytes; this was transient and gone by 24 hours. Radiographic image quality was judged good or excellent in almost all cases. Hexabrix is a contrast agent that is significantly better tolerated than conventional agents and is associated with no greater incidence of side-effects while producing radiographic images of equivalent quality.