Cardiac Arrest Clinical Trial
Official title:
Effect of High Dose Selenium on Inflammation and Neurological Outcome After Cardiac Arrest: A Randomized, Double Blind Placebo Controlled Phase 2a Study
After cardiac arrest and successful resuscitation it can happen that the brain function of a patient is impaired because the brain was without oxygen for a prolonged period of time. Several strategies have been studied to improve brain function after cardiac arrest. Cooling of the patients is routinely used today. The trace element selenium has several biological functions and is important for defense mechanisms against oxidative stress, which occurs after cardiac arrest and successful resuscitation. critically ill patients have low selenium blood levels. Therefore the investigators hypothesize that giving selenium after cardiac arrest and successful resuscitation might improve brain function.
When cardiopulmonary resuscitation results in the return of spontaneous circulation,
intensive care is required to optimize neurological recovery. The pathophysiological
reactions that follow hypoxic brain injury are complex, and the mechanisms by which ischemia
causes neuronal death leading to postanoxic encephalopathy are only partly understood to
date. Therapeutic hypothermia improves brain function after cardiopulmonary resuscitation.
Injury however can be ongoing even after the return of spontaneous circulation, giving the
clinician an additional window of opportunity to treat and protect the injured brain [5].
Therefore there is an unmet clinical need for further therapeutic strategies. Strategies to
counteract the deleterious effects of oxygen-derived free radicals after cerebral reperfusion
have been studied for long.
The trace element selenium is part of the enzyme glutathione peroxidase which belongs to the
endogenous defence mechanisms against oxidative stress. Clinical data suggest that
supplementation of selenium may be beneficial in critically ill patients and in
neurodegenerative diseases including, among others, Parkinson's disease, stroke, and
epilepsy, where oxidative stress plays an important pathophysiological role. In SIRS, sepsis
and septic shock doses up to 4000µg per day have been proven to be safe A recent
retrospective analysis supported the hypothesis that early administration of selenium may
improve neurological outcome after cardiac arrest.
Therefore the purpose of this study is to explore the influence of early administration of
selenium on neurological outcome after cardiopulmonary resuscitation by a randomized,
placebo-controlled, single-center study.
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