Last updated on September 2018

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


Brief description of study

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.

Detailed Study Description

Over a million patients undergo open heart surgery annually and this number is likely to accelerate as the population ages and the prevalence of diabetes and cardiovascular disease continue to increase. Unfortunately, death, organ failure, and other serious complications are all too frequent following open heart surgery, especially in some high-risk patient populations.

Selenium is a trace element that is important for many of the body's regulatory and metabolic functions especially during times of stress. International members of the study team have shown in a non-randomized study that high dose selenium supplementation was associated with improved clinical outcomes compared to a historical control group. The next step in this program of research is to conduct a randomized trial.

The aim of this 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 fewer complications, less organ injury and fewer deaths.

The investigators propose to conduct a randomized, placebo-controlled, double-blind, multicentre definitive trial of 1400 patients across 20 sites in Germany and Canada, which will include the pilot study patients. An industry partner (Biosyn) will provide the product and some additional support for the European sites. Patients will be randomized to receive either a daily perioperative high-dose selenium or placebo until postoperative day 10 (maximum) or upon earlier discharge from ICU. If the hypothesis is proven true, and this simple, inexpensive nutrient reduces complications and improves recovery of patients undergoing cardiac surgery, there is the potential to dramatically change clinical practice and improve health outcomes.

Clinical Study Identifier: NCT02002247

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Whitlock Richard, MD

Hamilton General Hospital
Hamilton, ON Canada
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Phil Jones, MD

London Health Sciences Centre
London, ON Canada
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Bernard J McDonald, MD

University of Ottawa Heart Institute
Ottawa, ON Canada
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Robert Fowler, MD

Sunnybrook Health Sciences Centre
Toronto, ON Canada
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David Mazer, MD

St. Michael's Hospital
Toronto, ON Canada
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Matteo Parotto, MD

Toronto General Hospital
Toronto, ON Canada
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Yoan Lamarche, MD

Institut de cardiologie de Montreal
Montreal, QC Canada
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Roupen Hatzakorzian, MD

McGill University Health Centre
Montreal, QC Canada
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Yoan Lamarche, MD

Sacre Coeur
Montreal, QC Canada
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Siamak Mohammadi, MD

IUCPQ
Quebec City, QC Canada
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Christian Stoppe, MD

RWTH Aachen University Hospital
Aachen, Germany
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Maria Wittman, MD

Klinik und Poliklinik f r An sthesiologie und Operative Intensivmedizin Universit tsklinikum Bonn
Bonn, Germany
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Patrick Meybohm, MD

Universit tsklinikum Frankfurt
Frankfurt, Germany
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Georg Trummer, MD

Klinik f r Her- und Gef chirurgie Universit ts-Herzzentrum Freiburg
Freiburg, Germany
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Gunnar Elke, MD

University Medical Center Schleswig-Holstein
Kiel, Germany
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Oliver Liakopoulos, MD

Klinik und Poliklinik f r Herz- und Thoraxchirurgie Uniklinik K ln
Koln, Germany
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Rita Laufenberg, MD

Klinik f r An sthesiologie Universit tsmedizin Mainz
Mainz, Germany
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Malte Book, MD

Klinikum Oldenburg gGmbH Universit tsklinik f r An sthesiologie / Intensivmedizin / Notfallmedizin / Schmerztherapie
Oldenburg, Germany
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Frank Kletzin

Klinik und Poliklinik f r An sthesiologie und Intensivtherapie Universit tsmedizin Rostock
Rostock, Germany
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Matthew Cameron, MD

Sir Mortimer B. Davis Jewish General Hospital
Montreal, QC Canada
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Bernd Niemann, MD

Klinik f r Herz-, Kinderherz- und Gef chirurgie UKGM Giessen
Gießen, Germany
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Erich Kilger, MD

Klinik f r An sthesiologie Klinikum der Universit t M nchen
München, Germany
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Thomas Ermert, MD

Klinik f r An sthesiologie, operative Intensivmedizin und Schmerztherapie Universit tsmedizin M nster, Zentralklinikum
Münster, Germany
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Recruitment Status: Open


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