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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  This trial was registered at Clinicaltrials.gov (identifier: NCT02002247) on 28 November 2013.
authors.affiliation: Department of Anesthesiology, University Hospital of the RWTH Aachen, Pauwelsstraße 30, 52074 Aachen, Germany. christian.stoppe@gmail.com.
authors.forename: Christian
authors.initials: C
authors.lastname: Stoppe
authors.forename: Bernard
authors.initials: B
authors.lastname: McDonald
authors.forename: Steffen
authors.initials: S
authors.lastname: Rex
authors.forename: William
authors.initials: W
authors.lastname: Manzanares
authors.forename: Richard
authors.initials: R
authors.lastname: Whitlock
authors.forename: Stephen
authors.initials: S
authors.lastname: Fremes
authors.forename: Robert
authors.initials: R
authors.lastname: Fowler
authors.forename: Yoan
authors.initials: Y
authors.lastname: Lamarche
authors.forename: Patrick
authors.initials: P
authors.lastname: Meybohm
authors.forename: Christoph
authors.initials: C
authors.lastname: Haberthür
authors.forename: Rolf
authors.initials: R
authors.lastname: Rossaint
authors.forename: Andreas
authors.initials: A
authors.lastname: Goetzenich
authors.forename: Gunnar
authors.initials: G
authors.lastname: Elke
authors.forename: Andrew
authors.initials: A
authors.lastname: Day
authors.forename: Daren K
authors.initials: DK
authors.lastname: Heyland
mesh_terms: D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000975:Antioxidants / Q000008:administration & dosage* / Q000009:adverse effects; D006348:Cardiac Surgical Procedures / Q000009:adverse effects* / Q000401:mortality; D002985:Clinical Protocols; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005060:Europe; D006801:Humans; D009102:Multiple Organ Failure / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D009656:North America; D019990:Perioperative Care; D011446:Prospective Studies; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D018038:Sodium Selenite / Q000008:administration & dosage* / Q000009:adverse effects; D013020:South America; D018746:Systemic Inflammatory Response Syndrome / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D000975:Antioxidants; D018038:Sodium Selenite