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Drug Used to Treat Kidneys Post Cardiac Surgery did not Lower Risk of Dialysis

Update Date: Sep 29, 2014 10:05 AM EDT

In a new study, researchers compared patients' risk of dialysis, also known as renal replacement therapy, after undergoing cardiac surgery. They found that the drug used to treat kidneys was not any more effective than a placebo in reducing the patient's need for a dialysis or in lowering their risk of death at 30 days.

According to the researchers, more than one million people undergo heart surgery annually within the United States and Europe. One of the most common side effects that arises is acute kidney injury. Doctors have used fenoldopan both as a prevention method and as treatment. However, the drug's effectiveness has not been fully studied with definitive trials.

In this study, the researchers headed by Tiziana Bove, M.D., of the IRCCS San Raffaele Scientific Institute, Milan, Italy recruited 667 patients who were from 19 intensive care units. They were admitted to these units post cardiac surgery between March 2008 and April 2013 and suffered from early acute kidney injury. 338 of them were randomly assigned to receive an infusion of fendolopam whereas the remaining 329 patients were given a placebo drug and acted as the control group.

In the drug group, 20 percent of the patients, or 69 of them, needed dialysis, whereas in the placebo group, 18 percent or 60 patients also needed dialysis. In terms of 30-day mortality, the rate in the drug group was 23 percent (78 patients) and the rate in the placebo group was 22 percent (74 patients). The study was stopped after a safety committee concluded that it would be futile to continue since the drug did not improve the patient's risks of dialysis or 30-day mortality.

"Given the cost of fenoldopam, the lack of effectiveness, and the increased incidence of hypotension, the use of this agent for renal protection in these patients is not justified," the authors stated according to the press release.

The one major difference that the researchers did find between fendolopam and the placebo was their effect on blood pressure. 26 percent of the patients from the drug group (85 patients) suffered from hypotension, also known as abnormally low blood pressure whereas only 15 percent of patients (49) from the other group did as well.

The study was presented at the European Society of Intensive Care Medicine annual congress and it was published in JAMA.

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