SodiUm SeleniTe Adminstration IN Cardiac Surgery (SUSTAIN CSX®-Trial).

Summary

The aim of the investigators' research program is to investigate the effects of perioperative high dose selenium supplementation in high-risk cardiac surgical patients undergoing complicated open heart surgery. The investigators hypothesize that the therapeutic strategy tested in this randomized trial may contribute to a fewer complications, less organ injury and fewer deaths. Before the investigators conducted the large definitive trial, they conducted a pilot study to assess the feasibility of the protocol, and are rolling the pilot patients into the definitive trial.

Timeline

Start

2015-01

Primary completion

2021-02

Completion

2021-07

Publications

• Dresen E, Heyland DK, Lee ZY, O'Brien B, Elke G, Radke DI, Meybohm P, Schoenrath F, Sundermann SH, von Dossow V, McDonald B, Christopher KB, Fremes SE, Mohammadi S, Niemann B, Boning A, Mazer CD, Ke L, Zarbock A, Day AG, Stoppe C. Pre- and Immediate Postoperative Prediction Model for Organ Dysfunction or Death Early After Cardiac Surgery: A Post Hoc Analysis of a Multicenter Randomized Trial. J Am Heart Assoc. 2026 Jul 17:e044394. doi: 10.1161/JAHA.125.044394. Online ahead of print.
• Stoppe C, McDonald B, Meybohm P, Christopher KB, Fremes S, Whitlock R, Mohammadi S, Kalavrouziotis D, Elke G, Rossaint R, Helmer P, Zacharowski K, Gunther U, Parotto M, Niemann B, Boning A, Mazer CD, Jones PM, Ferner M, Lamarche Y, Lamontagne F, Liakopoulos OJ, Cameron M, Muller M, Zarbock A, Wittmann M, Goetzenich A, Kilger E, Schomburg L, Day AG, Heyland DK; SUSTAIN CSX Study Collaborators. Effect of High-Dose Selenium on Postoperative Organ Dysfunction and Mortality in Cardiac Surgery Patients: The SUSTAIN CSX Randomized Clinical Trial. JAMA Surg. 2023 Mar 1;158(3):235-244. doi: 10.1001/jamasurg.2022.6855.
• Stoppe C, McDonald B, Rex S, Manzanares W, Whitlock R, Fremes S, Fowler R, Lamarche Y, Meybohm P, Haberthur C, Rossaint R, Goetzenich A, Elke G, Day A, Heyland DK. SodiUm SeleniTe Adminstration IN Cardiac Surgery (SUSTAIN CSX-trial): study design of an international multicenter randomized double-blinded controlled trial of high dose sodium-selenite administration in high-risk cardiac surgical patients. Trials. 2014 Aug 28;15:339. doi: 10.1186/1745-6215-15-339.

Drugs

Indications