Pause to think about POISE

One of the largest AKI trials was presented at ASN Kidney week 2014 and just published in JAMA as well- POISE 2.  It was a trial to look at a preventive strategy for AKI in non cardiac surgery setting.   An international trial, with 88 centers, 22 countries, from 2011-2013 of over 6000 patients was done to see if ASA or clonidine given prior to surgery prevented AKI post surgery.  Not to my surprise, a mong patients undergoing major noncardiac surgery, neither aspirin nor clonidine administered perioperatively reduced the risk of acute kidney injury. In addition, the ASA group had more risk of bleeding and the clonidine arm had more risk of hypotension. 

The logic behind using this strategy doesn’t make sense to me.  There are few trials in the surgical literature that might have prompted this trial.

The ASA data
The Clonidine data

The funding was provided by the CIHR, Spanish ministry of health and few other funding pharm agencies.  A multi international trial of AKI that might be one of the largest to date is an amazing ordeal but the concept seemed less likely to have worked.  A drug that causes bleeding and another one that causes hypotension is more likely to cause harm then benefit.  Ischemic re conditioning or sonogram might have been an interesting approach.