| Title: |
Effect of High-Dose Selenium on Postoperative Organ Dysfunction and Mortality in Cardiac Surgery Patients ; The SUSTAIN CSX Randomized Clinical Trial |
| 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.; 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 |
| Source: |
JAMA Surgery ; volume 158, issue 3, page 235 ; ISSN 2168-6254 |
| Publisher Information: |
American Medical Association (AMA) |
| Publication Year: |
2023 |
| Description: |
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 ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1001/jamasurg.2022.6855 |
| Availability: |
https://doi.org/10.1001/jamasurg.2022.6855; https://jamanetwork.com/journals/jamasurgery/articlepdf/2800335/jamasurgery_stoppe_2023_oi_220102_1678202776.53255.pdf |
| Accession Number: |
edsbas.C2F9577B |
| Database: |
BASE |