Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02002247
Study type Interventional
Source Clinical Evaluation Research Unit at Kingston General Hospital
Contact
Status Active, not recruiting
Phase Phase 3
Start date January 2015
Completion date July 2021

See also
  Status Clinical Trial Phase
Completed NCT03481322 - Low Sodium Cooking Study N/A
Completed NCT00001638 - Magnetic Resonance Imaging of the Blood Vessels of the Heart
Completed NCT02376244 - The Health Impact of High Intensity Exercise Training With Intervals During Cardiac Rehabilitation N/A
Completed NCT02277379 - Prediction of Bleeding and Transfusion Outcomes and Assessment of Perioperative Platelet Reactivity in Cardiac Surgery N/A
Completed NCT02523144 - Dexmedetomidine in Children Having Transthoracic Echocardiography Phase 4
Completed NCT02045641 - Pleural and Pericardial Effusion Following Open Heart Surgery N/A
Completed NCT01871090 - Remote Device Interrogation In The Emergency Department N/A
Active, not recruiting NCT01400490 - Eicosapentaenoic Acid (EPA)and Docosahexaenoic Acid Study N/A
Completed NCT01192360 - Dynamic Contrast Enhanced Magnetic Resonance Perfusion Imaging in Congenital Heart Disease and Lung Disease Phase 3
Terminated NCT00935766 - Effect of Fish Oil (Omega-3 Fatty Acids) on Arteries Phase 3
Completed NCT00745446 - The Effect of a Retrofit Particle Trap on the Vascular Effects of Diesel Exhaust Inhalation N/A
Completed NCT00140816 - Dairy Products and Metabolic Effects (Norwegian Part) N/A
Completed NCT00178620 - Pre-hospital Administration of Thrombolytic Therapy With Urgent Culprit Artery Revascularization Phase 4
Completed NCT00013949 - Cardiovascular Vulnerability to Particulate Exposure N/A
Completed NCT01952171 - The Genetic Basis of Congenital Heart Disease in Africa
Recruiting NCT02933892 - Benefit of Transradial Approach in Chronic Kidney Disease Population Undergoing Cardiac Catheterization Phase 4
Completed NCT02923518 - Cardiac Screening of Middle Aged and Older Women and Men (Master Athletes)
Withdrawn NCT02838355 - Employing End Tidal Capnography in Continuous Flow Ventricular Assist Device Patients N/A
Terminated NCT02282163 - Evaluation of Safety and Efficacy of Lumason in Pediatric Echocardiography Phase 3
Active, not recruiting NCT02260466 - Prevalence and Post-surgical Outcomes of CARdiac Wild-type TransthyrEtin amyloidoSIs in Elderly Patients With Aortic steNosis Referred for Valvular Replacement. N/A