Clinical and experimental studies on the safety of gadolinium contrast agents in renal failure patient.

1998 Fiscal Year Final Research Report Summary

• Project/Area Number: 09670961
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Single-year Grants
• Section: 一般
• Research Field: Radiation science
• Research Institution: Nippon Medical School
• Principal Investigator: OKADA Susumu Nippon Medical School, Department of Radiology, Associate Professor, 医学部, 助教授 (00194358)
• Co-Investigator(Kenkyū-buntansha): KUMAZAKI Tatsuo Nippon Medical School, Department of Radiology, professor, 医学部, 教授 (10089675)
• Project Period (FY): 1997 – 1998
• Keywords: MRI / contrast medium / gadolinium / renal failure / hemodialysis

Research Abstract

In order to evaluate the safety and pharmacokinetics of gadolinium contrast agents in patients with hemodialysis, in vitro and clinical studies were performed. Gd-DTPA and Gd-HP-DO3A solutions were dialysed by standard methods. One classic type (cellulose acetate) and two high-performance types (PMMA and polyacrylonitrile) were used. Eleven dialysis patients underwent normal dose contrast injection followed by usual hemodialysis (HD). PMMA dialysis membranes were used for 8 patients and cellulose acetate membranes for 3 patients. Serum level of gadolinium, BUN and creatinin were analyzed before and after the 1st HD, after the 2nd, 3rd and 4th HD.Side effect and edema were carefully observed. In vitro studies showed that 11.1 hours of dialysis would be necessary to remove 97% of the injected dose of contrast agent by using a first-order kinetic model of dialysis time. When dialysis membranes and contrast agents were compared, statistically significant differences were noted between dialysis membrane and all contrast agents. In the clinical study, 79.1% of the contrast agent was dialyzed after the 1st dialysis and 99.6% after the 4th dialysis. These results showed that all contrast agents and both dialysis membranes were suitable. Neither changes in laboratory parameters nor side effects were observed. The present study suggests, consequently, there are no contraindications when using the ordinary dose of contrast agent even in patients with dialysis.