High-dose selenium not associated with a reduction in morbidity and mortality in high-risk cardiac surgery patients

1. In this randomized clinical trial of 1416 adult cardiac surgery patients, high-dose selenium did not increase the number of days alive and free from persistent organ dysfunction 30 days post-cardiac surgery compared to placebo. 

2. The overall rate of persistent organ dysfunction plus death was 31.1% at day 2, 6.7% at day 14, and 6.2% at day 30 post-cardiac surgery. 

Evidence Rating Level:1 (Excellent)       

Study Rundown: Nearly 20% of cardiac surgery patients require immediate post-operative life-support, which negatively impacts long-term survival and quality of life. Oxidative stress from ischemia-reperfusion injury following cardiac surgery can trigger an intense inflammatory response and cause injury to all major organ systems. In cardiac surgery patients, low selenium levels are associated with post-operative multiorgan failure. Selenium supplementation is known to reduce organ dysfunction, acting on anti-inflammatory pathways. The objective of this randomized controlled trial was to assess the ability of high-dose intravenous sodium selenite treatment to reduce post-operative organ dysfunction and mortality in cardiac surgery patients. A total of 1416 adult cardiac surgery patients were included. Patients were randomly assigned to receive either perioperative intravenous high-dose selenium supplementation (2000 ug/L) of sodium selenite before cardiopulmonary bypass (CPB), immediately postoperatively (2000 ug/L), each day in intensive care for a maximum of 10 days (1000 ug/L), or placebo. The main outcome was the number of days alive and free from organ dysfunction 30 days post-cardiac surgery. The overall rate of persistent organ dysfunction plus death was 31.1% at day 2, 6.7% at day 14, and 6.2% at day 30 post-cardiac surgery. Compared to placebo, high dose selenium did not increase the number of days alive and free from persistent organ dysfunction 30 days post-cardiac surgery. A limitation of this study was that the population was predominantly male, which makes it difficult to understand and further address the implications of potential sex-specific factors. A strength was its use of robust scientific methods, including a randomized and blinded study design which augmented the validity of the trial.  

Click to read the study in JAMA Surgery

Relevant Reading: Selenium in cardiac surgery

In-Depth [randomized controlled trial]: This study investigated the ability of high-dose sodium selenite treatment to reduce post-operative organ dysfunction and mortality in cardiac surgery patients. The trial occurred at 23 sites in Germany and Canada between 2015 and 2021. A total of 1416 adult cardiac surgery patients (mean [SD] age, 68.2 [10.4] years; 1043 [74.8%] male) were included. Patients were randomly assigned (1:1) to receive either perioperative intravenous high-dose selenium supplementation of 2000 ug/L of sodium selenite before CPB, 2000 ug/L immediately postoperatively,1000 ug/L each day in intensive care for a maximum of 10 days, or placebo. The primary endpoint was a composite of the number of days alive and free from organ dysfunction 30 days post-cardiac surgery. The overall rate of persistent organ dysfunction plus death was 31.1% (n=434) at day 2, 6.7% (n=94) at day 14, and 6.2% (n=86) at day 30. The median (IQR) predicted 30-day mortality by European System for Cardiac Operative Risk Evaluation II score was 8.7% (5.6%-14.9%). The 30-day mortality rate was 4.2% (n=29) in the selenium and 5.0% (n=35) in the placebo group (OR, 0.82; 95% CI, 0.50-1.36; P = .44). The 6-month survival rate was similar between the treatment groups (HR, 1.00; 95% CI, 0.68 – 1.47; P = .98). In the selenium groups 57 patients (8.2%) had at least one serious adverse event, compared to 60 patients (8.6%) in the placebo group. 

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