Using highly concentrated gadobutrol as an MR contrast agent in patients also requiring hemodialysis: safety and dialysability.

OBJECTIVE: The purpose of our study was to assess the safety and dialysability of gadobutrol, a new, electrically neutral, and highly concentrated MR contrast agent, in patients who require hemodialysis. SUBJECTS AND METHODS: Eleven patients with end-stage renal failure who required ongoing hemodialysis were enrolled in our prospective study. Gadobutrol (1 mol/L) was injected IV at randomly assigned doses of either 0.1 or 0.3 mmol of gadolinium per kilogram of body weight for contrast-enhanced MR imaging. Hematology, clinical chemistry, and vital signs were closely monitored at baseline and during an observation period of 120 hr after the IV injection of gadobutrol. To calculate the dialysability, blood samples were drawn before and after each of three hemodialysis sessions. Additional arterial and venous blood sampling was performed during the first hemodialysis session after 30 and 90 min.
RESULTS: No gadobutrol-related changes in hematology, clinical chemistry, or vital signs were detected at either dose level during the observation period. The mean and the standard deviation for the eliminated fraction of gadobutrol was 68.2% +/- 12.7% after a 3-hr hemodialysis session using a 1.2 m(2) low-flux polysulfone membrane. After three consecutive hemodialysis sessions, the total amount of gadobutrol eliminated increased to 98.0% +/- 1.8%. The mean clearance rates of gadobutrol were 126.1 +/- 17.8 mL/min and 126.6 +/- 24.5 mL/min at 30 and 90 min, respectively.
CONCLUSION: Gadobutrol is effectively removed by three hemodialysis sessions using a low-flux polysulfone membrane. Our study documents initial evidence that gadobutrol can be used safely in hemodialysis patients.

RCT Entities:   Population Interventions Outcomes