Approach could lower contrast-induced nephropathy incidence by as much as 65%, study says.
SEATTLE—Fenoldopam delivered into the renal artery may help prevent contrast-induced nephropathy (CIN).
The finding comes from a study looking at administration of fenoldopam into renal arteries using the Benephit Infusion System (Flow-Medica Inc.). This approach could reduce CIN in high-risk patients by as much as 65%, according to interventional radiologist Bret Wiechmann, MD, who presented results here at the annual meeting of the Society for Interventional Radiology.
He and his colleagues analyzed data in the Benephit System Renal Infusion Therapy (BeRITe!) Registry, a retrospective, observational, multicenter study designed to assess post-market device safety and determine usage patterns of the Benephit system. The researchers examined the incidence of CIN, which was defined as a greater than 25% increase in serum creatinine 48 hours after patients received iodinated contrast media.
More than 400 patients at high risk for CIN have been entered into the BeRITe! Registry, and 150 have evaluable data for CIN incidence at 48 hours. Of the 150 patients, 94% had pre-existing renal impairment. Their mean baseline serum creatinine was 2.0 mg/dL; 88% had creatinine clearance less than 60 mL/min.
A total of 135 patients (91%) received intra-renal fenoldopam (0.05-0.8 mcg/kg/min) and 15 (6%) received intrarenal sodium bicarbonate (154 meq/L, 1-2 mL/kg/hr). The remaining 3% received alprostadil. The mean infusion time was 162 minutes.
At 48 hours, the mean serum creatinine level was 2.1 mg/dL. The CIN incidence in the intrarenal fenol-dopam group was 9.6% compared with a predicted CIN incidence of 29%. Only four (1.4%) minor complications were reported: two hematomas, a mild renal dissection, and a case of hypotension.
“There is a lack of consistent data for the current regimens that we use for CIN prophylaxis. No real standard of care has emerged,” said Dr. Wiechmann, chief of interventional radiology at NorthFloridaRegionalMedicalCenter in Gainesville and clinical associate professor of radiology at the University of Florida in Gainesville. “The results are encouraging, with a markedly reduced incidence of CIN compared to a predictive model for CIN in high-risk patients. It is very promising.”