Drug For Kidneys Post Cardiac Surgery Did Not Lower Dialysis Risk

First Posted: Sep 29, 2014 03:51 PM EDT
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Recent findings published in JAMA show that patients' risk of dialysis following cardiac surgery were not any more effective following a placebo in reducing their need for a dialysis or lowering their risk of death at 30 days.

As more than one million undergo heart surgery annually throughout the United States and Europe, the most common side effect remains acute kidney injury. However, doctors oftentimes use fenoldopan both as a prevention method and as a treatment for the problem. Yet the effectiveness has not been fully studied with definitive trials.

For their research, study authors 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. From the sample, 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.

Findings revealed that about 20 percent of the patients needed dialysis. In the placebo group, on the other hand, only about 18 percent did. In terms of 30-day mortality rate, the drug group was about 23 percent and the rate in the placebo group was about 22 percent. 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, in a news release. 

However, study authors noted that one major difference was between fendolopam and the placebo group on blood pressure. About 26 percent of the patients from the drug group suffered from hypotension whereas only 15 percent of patients from the other group did.

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