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Published in: Trials 1/2014

Open Access 01-12-2014 | Study protocol

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

Authors: Christian Stoppe, Bernard McDonald, Steffen Rex, William Manzanares, Richard Whitlock, Stephen Fremes, Robert Fowler, Yoan Lamarche, Patrick Meybohm, Christoph Haberthür, Rolf Rossaint, Andreas Goetzenich, Gunnar Elke, Andrew Day, Daren K Heyland

Published in: Trials | Issue 1/2014

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Abstract

Background

Cardiac surgery has been shown to result in a significant decrease of the antioxidant selenium, which is associated with the development of multiorgan dysfunction and increased mortality. Thus, a large-scale study is needed to investigate the effect of perioperative selenium supplementation on the occurrence of postoperative organ dysfunction.

Methods/Design

We plan a prospective, randomized double-blind, multicenter controlled trial, which will be conducted in North and South America and in Europe. In this trial we will include 1,400 high-risk patients, who are most likely to benefit from selenium supplementation. This includes patients scheduled for non-emergent combined and/or complex procedures, or with a predicted operative mortality of ≥5% according to the EuroSCORE II. Eligible patients will be randomly assigned to either the treatment group (bolus infusion of 2,000 μg sodium selenite immediately prior to surgery, followed by an additional dosage of 2,000 μg at ICU admission, and a further daily supplementation of 1,000 μg up to 10 days or ICU discharge) or to the control group (placebo administration at the same time points).

The primary endpoint of this study is a composite of 'persistent organ dysfunction’ (POD) and/or death within 30 days from surgery (POD + death). POD is defined as any need for life-sustaining therapies (mechanical ventilation, vasopressor therapy, mechanical circulatory support, continuous renal replacement therapy, or new intermittent hemodialysis) at any time within 30 days from surgery.

Discussion

The SUSTAIN-CSX™ study is a multicenter trial to investigate the effect of a perioperative high dosage sodium selenite supplementation in high-risk cardiac surgical patients.

Trial registration

This trial was registered at Clinicaltrials.gov (identifier: NCT02002247) on 28 November 2013.

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Metadata
Title
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
Authors
Christian Stoppe
Bernard McDonald
Steffen Rex
William Manzanares
Richard Whitlock
Stephen Fremes
Robert Fowler
Yoan Lamarche
Patrick Meybohm
Christoph Haberthür
Rolf Rossaint
Andreas Goetzenich
Gunnar Elke
Andrew Day
Daren K Heyland
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Trials / Issue 1/2014
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-15-339

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