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

  • STATUS
    Recruiting
  • days left to enroll
    9
  • participants needed
    1400
  • sponsor
    Daren K. Heyland
Updated on 6 June 2021
Investigator
Daren K Heyland, MD
Primary Contact
Klinik und Poliklinik f r Herz- und Thoraxchirurgie Uniklinik K ln (0.0 mi away) Contact
+33 other location
anesthesia
bypass graft
heart surgery

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.

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.

Details
Condition Heart disease, Cardiovascular Disease, Cardiac Disease, cardiac diseases, heart diseases, cardiac disorders, cardiac disorder, heart disorder
Treatment Placebo, sodium selenite, sodium selenite
Clinical Study IdentifierNCT02002247
SponsorDaren K. Heyland
Last Modified on6 June 2021

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