Effect of High-Dose Selenium on Postoperative Organ Dysfunction and Mortality in Cardiac Surgery Patients
Authors: Stoppe Christian , McDonald Bernard , Meybohm Patrick , Christopher Kenneth B. , Fremes Stephen , Whitlock Richard , Mohammadi Siamak , Kalavrouziotis Dimitri , Elke Gunnar , Rossaint Rolf , Helmer Philipp , Zacharowski Kai , Günther Ulf , Parotto Matteo , Niemann Bernd , Böning Andreas , Mazer C. David , Jones Philip M. , Ferner Marion , Lamarche Yoan , Lamontagne Francois , Liakopoulos Oliver J. , Cameron Matthew , Müller Matthias , Zarbock Alexander , Wittmann Maria , Goetzenich Andreas , Kilger Erich , Schomburg Lutz , Day Andrew G. , Heyland Daren K. ,   SUSTAIN CSX Study Collaborators, Hare Gregory , Chu Michael WA , Voisine Pierre , Dagenais Francois , Dumont Eric , Jacques Frédérique , Charbonneau Eric , Perron Jean , Lindau Simone , Hatzakorizan Roupen , Haneya Assad , Trummer Georg , Jareth Angela , Jiang Xuran , Dresen Ellen , Hill Aileen 
Published: January 2023

Importance

Selenium contributes to antioxidative, anti-inflammatory, and immunomodulatory pathways, which may improve outcomes in patients at high risk of organ dysfunctions after cardiac surgery.

Objective

To assess the ability of high-dose intravenous sodium selenite treatment to reduce postoperative organ dysfunction and mortality in cardiac surgery patients.

Design, Setting, and Participants

This multicenter, randomized, double-blind, placebo-controlled trial took place at 23 sites in Germany and Canada from January 2015 to January 2021. Adult cardiac surgery patients with a European System for Cardiac Operative Risk Evaluation II score–predicted mortality of 5% or more or planned combined surgical procedures were randomized.

Interventions

Patients were randomly assigned (1:1) by a web-based system to receive either perioperative intravenous high-dose selenium supplementation of 2000 μg/L of sodium selenite prior to cardiopulmonary bypass, 2000 μg/L immediately postoperatively, and 1000 μg/L each day in intensive care for a maximum of 10 days or placebo.

Main Outcomes and Measures

The primary end point was a composite of the numbers of days alive and free from organ dysfunction during the first 30 days following cardiac surgery.

Results

A total of 1416 adult cardiac surgery patients were analyzed (mean [SD] age, 68.2 [10.4] years; 1043 [74.8%] male). The median (IQR) predicted 30-day mortality by European System for Cardiac Operative Risk Evaluation II score was 8.7% (5.6%-14.9%), and most patients had combined coronary revascularization and valvular procedures. Selenium did not increase the number of persistent organ dysfunction–free and alive days over the first 30 postoperative days (median [IQR], 29 [28-30] vs 29 [28-30]; P = .45). The 30-day mortality rates were 4.2% in the selenium and 5.0% in the placebo group (odds ratio, 0.82; 95% CI, 0.50-1.36; P = .44). Safety outcomes did not differ between the groups.

Conclusions and Relevance

In high-risk cardiac surgery patients, perioperative administration of high-dose intravenous sodium selenite did not reduce morbidity or mortality. The present data do not support the routine perioperative use of selenium for patients undergoing cardiac surgery.

Trial Registration

ClinicalTrials.gov Identifier: NCT02002247