Grant: Operating Grant

Over a million patients undergo open heart surgery annually and this number is likely to accelerate as the population ages and the number of people with diabetes and cardiovascular disease continues to increase. Unfortunately, death, organ failure, and other serious complications are all too frequent following open heart surgery, especially in some high-risk patient populations. Selenium is a trace element that is important for many of the body's regulatory and metabolic functions especially during times of stress. International members of our study team have shown in a non-randomized study that high dose selenium supplementation was associated with improved clinical outcomes compared to a historical control group. The next step in our program of research is to conduct a randomized trial. The aim of our research program is to investigate the effects of giving high dose selenium supplementation to high-risk cardiac surgical patients undergoing complicated open heart surgery. We hypothesize that this therapeutic strategy will contribute to fewer complications, less organ injury and fewer deaths. Before we conduct a very large and expensive international trial testing this hypothesis, we must first conduct a pilot study to assess the feasibility of our approach. We propose to conduct a randomized, placebo-controlled, double-blind, multicentre pilot study of 160 patients in 8 sites located in Belgium, Germany, U.S. and Canada. We have an industry partner (Biosyn) that will provide us with the product and financial support for the European sites. Cardiac surgery patients will be randomized to receive either a daily high-dose of selenium or placebo until postoperative day 10 (maximum) or upon earlier discharge from ICU. If our hypothesis is proven true, and this simple, inexpensive nutrient reduces complications and improves recovery of patients undergoing cardiac surgery, we have the potential to dramatically change clinical practice and improve health outcomes.