1. 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.
- Author
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Stoppe C, McDonald B, Rex S, Manzanares W, Whitlock R, Fremes S, Fowler R, Lamarche Y, Meybohm P, Haberthür C, Rossaint R, Goetzenich A, Elke G, Day A, and Heyland DK
- Subjects
- Anti-Inflammatory Agents adverse effects, Antioxidants adverse effects, Cardiac Surgical Procedures mortality, Clinical Protocols, Double-Blind Method, Drug Administration Schedule, Europe, Humans, Multiple Organ Failure etiology, Multiple Organ Failure mortality, North America, Perioperative Care, Prospective Studies, Risk Assessment, Risk Factors, Sodium Selenite adverse effects, South America, Systemic Inflammatory Response Syndrome etiology, Systemic Inflammatory Response Syndrome mortality, Time Factors, Treatment Outcome, Anti-Inflammatory Agents administration & dosage, Antioxidants administration & dosage, Cardiac Surgical Procedures adverse effects, Multiple Organ Failure prevention & control, Research Design, Sodium Selenite administration & dosage, Systemic Inflammatory Response Syndrome prevention & control
- 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.
- Published
- 2014
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