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
| العنوان: | 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 |
|---|---|
| المؤلفون: | Stephen E. Fremes, Andrew E Day, Andreas Goetzenich, Robert A. Fowler, Yoan Lamarche, Christian Stoppe, Bernard McDonald, Gunnar Elke, Daren K. Heyland, Christoph Haberthür, Patrick Meybohm, William Manzanares, Steffen Rex, Rolf Rossaint, Richard P. Whitlock |
| المصدر: | Trials Trials 15, 339 (2014). doi:10.1186/1745-6215-15-339 |
| بيانات النشر: | BioMed Central, 2014. |
| سنة النشر: | 2014 |
| مصطلحات موضوعية: | medicine.medical_specialty, Time Factors, medicine.medical_treatment, Multiple Organ Failure, Postoperative organ failure, Anti-Inflammatory Agents, Medicine (miscellaneous), Placebo, Risk Assessment, Antioxidants, Drug Administration Schedule, Perioperative Care, law.invention, Study Protocol, Selenium, Sodium Selenite, Randomized controlled trial, Clinical Protocols, Double-Blind Method, law, Risk Factors, Multicenter trial, medicine, Clinical endpoint, Humans, Pharmacology (medical), Renal replacement therapy, Prospective Studies, Myocardial ischemia/reperfusion, Cardiac Surgical Procedures, business.industry, Organ dysfunction, Inflammatory response, Perioperative, South America, Systemic Inflammatory Response Syndrome, 3. Good health, Cardiac surgery, Surgery, Antioxidant capacity, Europe, Treatment Outcome, Oxidative stress, Research Design, North America, medicine.symptom, business |
| الوصف: | 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. Electronic supplementary material The online version of this article (doi:10.1186/1745-6215-15-339) contains supplementary material, which is available to authorized users. |
| اللغة: | English |
| تدمد: | 1745-6215 |
| DOI: | 10.1186/1745-6215-15-339 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a62224afd4029906ae38cb035de6ee22 http://europepmc.org/articles/PMC4247649 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....a62224afd4029906ae38cb035de6ee22 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 17456215 |
|---|---|
| DOI: | 10.1186/1745-6215-15-339 |