Selenium to Improve Neurological Outcome After Cardiac Arrest
Ключови думи
Резюме
Описание
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.
Дати
Последна проверка: | 11/30/2017 |
Първо изпратено: | 07/03/2011 |
Очаквано записване подадено: | 07/06/2011 |
Първо публикувано: | 07/10/2011 |
Изпратена последна актуализация: | 12/11/2017 |
Последна актуализация публикувана: | 12/12/2017 |
Действителна начална дата на проучването: | 12/31/2016 |
Приблизителна дата на първично завършване: | 06/30/2018 |
Очаквана дата на завършване на проучването: | 06/30/2019 |
Състояние или заболяване
Интервенция / лечение
Drug: Sodium-selenite infusion
Drug: Placebo
Фаза
Групи за ръце
Arm | Интервенция / лечение |
---|---|
Active Comparator: Sodium-selenite infusion Di-sodium-selenite-pentahydrate (Na 2SeO3.5H2O) in 0,9% sodium chloride is administered intravenously at a does of 3000µg on day 0, 2000µg on day 1 and 2 and at a dose of 1000µg per day on day 3-6. | Drug: Sodium-selenite infusion Di-sodium-selenite-pentahydrate (Na 2SeO3.5H2O) in 0,9% sodium chloride is administered intravenously at a does of 3000µg on day 0, 2000µg on day 1 and 2 and at a dose of 1000µg per day on day 3-6. |
Placebo Comparator: Placebo 0.9% sodium chloride | Drug: Placebo 0,9% sodium chloride is administered intravenously |
Критерии за допустимост
Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
Полове, допустими за проучване | All |
Приема здрави доброволци | Да |
Критерии | Inclusion Criteria: - Cardiac arrest - Successful Resuscitation - Age >18 Exclusion Criteria: - Polytrauma - Pregnancy - Any condition that makes it likely that the patient will not survive 24 hours |
Резултат
Първични изходни мерки
1. neuron specific enolase [72 hours]
Вторични изходни мерки
1. inflammation [7 days]
2. oxidative stress markers [7 days]
3. neurological function [6 months]
4. Selenium blood levels [7 days]
5. glutathion peroxidase plasma levels [7 days]