Ventricular Dysfunction, Left Clinical Trial
Official title:
Perioperative High-dose Selenium Supplementation in Patients With Left Ventricular Assist Device - a Double Blinded Randomised Controlled Trial
This planned pilot study is a monocentric, prospective, double-blind randomized and placebo
controlled clinical study. The SOS-LVAD Trial can be assigned to the clinical Phase III.
The aim of the present trial is to provide the scientific rationale for a large multicenter
clinical trial, investigating the effects of perioperative high dose selenium supplementation
in high-risk cardiac surgical patients undergoing complicated open heart surgery with
prolonged time on cardiopulmonary bypass (CPB) and LVAD Implant. The investigators
hypothesize that the therapeutic strategy tested in this randomized trial may contribute to a
faster independency from life-sustaining technologies in the ICU and a decrease of
postoperative morbidity and mortality. Before proceeding to the large-scale, definitive
trial, the investigators propose to conduct a pilot study of the definitive randomized trial,
to determine the feasibility of the study protocol.
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